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Grouping medical devices as an IVD Cluster

IVD reagents or articles with the same product owner that only fall under risk class B. They are of a common test methodology and fall under the same IVD cluster category.

IVD Cluster grouping requirements

An IVD Cluster comprises a number of in vitro diagnostic reagents or articles that are:

  • From the same product owner.
  • Of the same risk classification (Class B only).
  • Of a common test methodology.
  • Of the same IVD Cluster category.

The IVD Cluster may include analysers that are designed for use with the reagents in the IVD Cluster.

The listing of the IVD test kits, reagents and their accessories on the SMDR upon approval may differ from the initial grouping.

Types of IVD Clusters

IVD Clusters How to list
  • Individual (Single) reagents or articles.
  • Test kits.
  • Family of reagents or articles within an IVD Cluster.

List separately on the Singapore Medical Device Register (SMDR).

Note: The different device brand names, and common intended purpose would be key considerations for the separate listings.


  • IVD Clusters which include IVD analyser.
  • IVD Test Kit which include IVD analyser.

Select one of the following options:

  • List together as an IVD system.
  • List the IVD analyser separately from the IVD test kit as a split listing.

Grouping limitations

The IVD Cluster grouping is only used for product registration, and will not apply as a grouping criterion for the addition of models through a Change Notification.

All devices and articles that are listed as part of a Cluster can be supplied separately but solely for the registered intended purpose.

A reagent or article that is intended for multiple usage categories, such that it can be grouped in more than one IVD Cluster, can be grouped as part of any IVD Cluster.

List of IVD Cluster Categories

This list of IVD Cluster categories only applies to Class B IVD devices. The label of each reagent or article should state clearly whether it is intended to be used alone or in combination, for the same category.

Methodology Cluster Category (Closed list) Examples of analytes

Clinical chemistry

Enzymes

  • Acid Phosphatase
  • Alpha-Amylase
  • Creatine Kinase
  • Gamma-Glutamyl Transferase
  • Lactate Dehydrogenase
  • Lipase

Clinical chemistry

Substrates

  • Albumin
  • Bilirubin
  • Urea/blood urea nitrogen
  • Cholesterol
  • Creatinine
  • Glucose

Clinical chemistry

Electrolytes
Reagents
  • Ammonia
  • Bicarbonate
  • Calcium
  • Chloride
  • Magnesium
  • Phosphate inorganic/phosphorus

Clinical chemistry

Electrolyte
Electrodes

  • Ammonia electrodes
  • Carbon dioxide (bicarbonate) electrodes
  • Calcium electrodes
  • Chloride electrodes
  • Magnesium electrodes
  • Potassium electrodes

Clinical chemistry

Substrate electrodes/biosensors

  • Creatinine Electrodes
  • Glucose Electrodes
  • Glycated Hemoglobin Electrodes
  • Lactate Electrodes
  • Urea Electrodes
  • Bilirubin Electrodes

Immunochemistry

Immunoglobulins (without IgE)
  • Immunoglobulin A
  • Immunoglobulin D
  • Immunoglobulin G
  • Immunoglobulin M
  • Immunofixation kits

Immunochemistry

Complement components

  • Complement component C1q
  • Complement component C1 inactivator
  • Complement component C3/C3c
  • Complement component Bb
  • Complement component C4
  • Complement component C5a

Immunochemistry

Transport proteins

  • Albumin
  • Ceruloplasmin
  • Haptoglobin
  • Hemopixin
  • Lactoferrin
  • Pre-albumin/Transthyretin

Immunochemistry

Lipoproteins

  • Apolipoprotein A I
  • Apolipoprotein A II
  • Apolipoprotein B
  • Apolipoprotein E Sub-typing
  • Lipoprotein (a)

Immunochemistry

Other Specific Proteins


  • a1-Acid Glycoprotein
  • a1-Antitrypsin
  • a1- Microglobulin
  • Fribonectin
  • Immuno Reactive Trypsin

Immunochemistry

Allergy

  • Immunoglobuin E - Total
  • Immunoglobulin E - Screen
  • Immunoglobulin E - Specific, monotest/monoresult
  • Allergen specific IgA
  • Allergen specific IgG

Immunochemistry

Cancer markers
  • G1- marker CA242
  • p53

Immunochemistry

Thyroid function markers
  • Free triiodothyronine
  • Free thyroxine
  • Thyroid stimulating hormone
  • T-uptake
  • Thyroglobulin
  • Neonatal thyroxine

Immunochemistry

Fertility/Pregnancy Hormones/ Proteins
  • Androstenedione
  • Estradiol
  • Prolactin
  • Human Placental Lactogen
  • Estriol

Immunochemistry

Diabetes assays (hormones)
  • C-peptide
  • Glucagon
  • Insulin
  • Glycosylated/glycated haemoglobin
  • Islet Cell Ab
  • Proinsulin

Immunochemistry

Renal metabolism assays
  • Aldosterone
  • Angiotensin I/II
  • Angiotensin converting enzyme
  • Cortisol
  • Renine
Immunochemistry Bone and mineral metabolism assays
  • Bone alkaline phosphatase
  • Calcitonin
  • Cross-linked C-Telopeptides
  • Cross-linked N-Telopeptides
  • Cyclic adenosin monophosphate
  • Hydroxyproline
Immunochemistry Endocrine hormones and peptides
  • Adrenocorticotropic Hormone
  • Human Growth Hormone
  • Insulin-like Growth Factor I
  • Insulin-like Growth Factor Binding Protein 1
  • Vasointestinal Peptide
  • Vasopressin

Immunochemistry

Neuroendocrine Function Assays
  • Bombesin
  • 17-Hydroxy-Ketosterone
  • β-Endorphin
  • Neurotensin
  • Somatostatin
  • Substance P

Immunochemistry

Other individual and specified hormones
  • Gastrin
  • Gonadotropin-releasing hormone
  • Melatonin
  • Pepsinogen
  • Adrenalin
  • Dopamine

Immunochemistry

Anaemia
  • Erythropoietin
  • Ferritin
  • Folate
  • Iron
  • Iron binding capacity
  • Soluble transferrin receptor

Immunochemistry

Vitamins

  • Vitamin B1
  • Vitamin B2
  • Vitamin B6
  • Vitamin B12
  • Vitamin D (cholecalciferol)
  • Intrinsic factor (blocking antibody)

Immunochemistry

Drug monitoring
  • Caffeine
  • Benzodiazepines
  • Penicillins
  • Tetracyclines

Immunochemistry

Toxicology

  • Amphetamines
  • Cocaine
  • Morphine
  • Phencyclidine
  • Acetaminophen
  • Catecholamines
  • Ethanol
  • Salicylate

Immunochemistry

Auto-immune diseases
  • Anti-nuclear antibodies (ANAs)
  • Anti-topoisomerase
  • Organ-specific autoantibodies
  • Circulating Immuno-complex
  • TSH Receptor antibodies
  • Anti-Cardiolipin antibodies

Immunochemistry

Rheumatoid- Inflammatory diseases markers
  • Anti-Streptococcal Hyaluronidase
  • Anti-Streptokinase
  • Anti-Streptolysin O
  • C-Reactive Protein
  • Anti-Staphylolysin
  • Anti-Streptococcal Screening

Immunochemistry

Liver function
  • MEGX
  • Carbohydrate Deficient Transferrin

Immunochemistry

Cardiac markers
  • Homocysteine
  • ST2
  • Galectin-3
  • Myeloperoxidase (MPO)

Immunochemistry

Bacterial Infection - Immunology
  • Bacillus subtilis
  • Pseudomonas Aeruginosa
  • Helicobacter Pylori
  • Lactobacillus casei

Immunochemistry

Viral infection - Immunology
  • Norovirus
  • Rotavirus
  • Hantavirus

Immunochemistry

Parasitic Infection - Immunology
  • Leishmania

Immunochemistry

Fungal Infection - Immunology
  • Candida albicans
  • Aspergillus

Haematology/histology/cytology
(blood tests for transfusions excluded)



Haemoglobin testing


  • Hemoglobin determinations (Total Hb)
  • Fractional oxyhemoglobin (FO2Hb)
  • Fractional carboxyhemoglobin (FCOHb)
  • Fractional methemoglobin (FMetHb)
  • Fractional deoxyhemoglobin (FHHb)

Haematology/histology/cytology
(blood tests for transfusions excluded)

General coagulation tests


  • Prothrombin Time
  • Thrombin Time
  • Activated Clotting Time
  • Activated Partial Thromboplastin Time

Haematology/histology/cytology
(blood tests for transfusions excluded)

Haemostasis (coagulation)
  • Fibrinogen
  • Protein C and Protein S reagents
  • C1-inhibitors
  • Alpha-Antiplasmin
  • Fibrin
  • Factor XIII
  • Platelet Factor 4
  • Plasminogen

Haematology/histology/cytology
(blood tests for transfusions excluded)

Other hematology tests

  • Complete blood count
  • Hematocrit
  • Erythrocyte sedimentation rate

Haematology/histology/cytology
(blood tests for transfusions excluded)

Cytokines (lymphokines)/ immunomodulators

  • Interferons
  • Soluble antigens/receptors
  • Tumor necrosis factors
  • Colony stimulating factors
  • Tumor necrosis factors receptors

Haematology/histology/cytology
(blood tests for transfusions excluded)

Histology/cytology reagents
  • Cytochemical staining
  • Embedding, fixing, mounting media
  • Stain solutions
  • Immunohistology kits
Microbiology culture Culture media
  • Dehydrated culture media (DCM)
  • Additives for DCM
  • Prepared media (tubes, bottles, plates)
  • Cells, media, serum for viral culture
Microbiology culture Susceptibility testing
(Testing the susceptibility of bacteria to certain antibiotics)
  • Erythromycin susceptibility test for Staphylococcus aureus
  • Tobramycin susceptibility test for Pseudomonas aeruginosa
  • Fungal susceptibility testing

Microbiology culture

Biochemical culture Identification (ID)
  • Gram negative manual ID
  • Gram positive manual ID
  • Other ID kits manual - anaerobes, fastidious

Microbiology culture Immunological culture Identification (ID)
  • Streptococci grouping slide tests
  • Serotyping (Shigella etc.)
Microbiology culture Nucleic Acid (NA) based culture identification (ID)
  • Streptococci
  • Shigella
Microbiology culture Serological identification (ID) For Parasitology and Mycology (Fungi and Yeast)
Microbiology culture

Bacterial Infections

(detection by NA reagents)
  • Streptococci
  • Shigella
Microbiology culture Viral infections (detection by NA reagents) Para-influenza NA reagents
Microbiology culture Fungal infections
  • Fungi NA reagents
  • Candida albicans
  • Aspergillus
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