Grouping medical devices as an IVD Cluster

• 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.

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