(28 days)
Not Found
No
The device description details a biochemical assay based on enzymatic reactions and optical density measurements. There is no mention of AI/ML algorithms for data analysis, interpretation, or decision-making. The calculation of GALT activity is based on a direct measurement and a defined formula.
No.
The device is for in vitro diagnostic use only, designed to measure GALT activity for diagnosis and treatment monitoring, not to provide therapy itself.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "Measurements of GALT are used in the diagnosis and treatment of the hereditary disease galactosemia..." and "For in vitro diagnostic use only." The entire device description details how it determines GALT activity to aid in this diagnosis.
No
The device description details a chemical assay utilizing reagents, dried blood spot samples, and optical density readings, indicating it is a laboratory-based in vitro diagnostic device with significant hardware and chemical components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
- Purpose: The assay is designed to determine the activity of an enzyme (GALT) in a biological sample (dried blood spot) to aid in the diagnosis and treatment of a disease (galactosemia). This is a core function of an in vitro diagnostic device.
- Sample Type: It uses a biological sample (dried blood spot).
- Measurement: It measures a biological marker (GALT activity) to provide information about a patient's health status.
N/A
Intended Use / Indications for Use
This assay is for the qualitative determination of galactose-1-phosphate uridyl transferase (GALT) activity in dried blood spot samples. Measurements of GALT are used in the diagnosis and treatment of the hereditary disease galactosemia (disorder of galactose metabolism) in infants. For in vitro diagnostic use only.
Product codes
KQP
Device Description
The Microplate Neonatal GALT assay utilizes dried blood spot samples (DBS) eluted in a medium containing 8-nicitinamide adenine dinucleotide phosphate (NADP), galactose-1phosphate, uridine-5-diphosphoglucose (UDPG), and a tetrazolium salt. During elution, GALT present in the specimen converts galactose-1-phosphate to glucose-1-phosphate, with the eventual reduction of NADP to NADPH. After elution, an aliquot of the eluate is transferred to a microwell. The optical density (OD) is read, then Enzyme Reagent is added. During the incubation that follows, the Enzyme Reagent converts NADPH generated by GALT and endogenous red cell enzymes to NADP, and the tetrazolium salt to a colored formazan dye which is detected at 550 or 570 nm. The OD is read again and the difference between the two OD readings is determined. GALT activity, in units/g hemoglobin or units/liter blood, is calculated from the difference in signal between the two absorbance readings. A unit is defined as the quantity of GALT that catalyzes the formation of 1 micromole of UDP galactose per gram of hemoglobin or per Liter blood per hour at 37℃. An external calibrator is not necessary because enzyme activity is measured directly with substrates in excess.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
infants
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
| Performance Tests | Acceptance Criteria | Microplate Assay | RADIAS Assay |
|---|---|---|---|
| Concordance | 100% | 100%(to RADIAS) | 100%(To Beutler) |
| Analytical Sensitivity |
§ 862.1315 Galactose-1-phosphate uridyl transferase test system.
(a)
Identification. A galactose-1-phosphate uridyl transferase test system is a device intended to measure the activity of the enzyme galactose-1-phosphate uridyl transferase in erythrocytes (red blood cells). Measurements of galactose-1-phosphate uridyl transferase are used in the diagnosis and treatment of the hereditary disease galactosemia (disorder of galactose metabolism) in infants.(b)
Classification. Class II.
0
4/9/99
Special 510(k): Device Modification Summary
| Submitter: | Bio-Rad Laboratories, Inc.
4000 Alfred Nobel Drive,
Hercules, California 94547
Phone: (510) 741-6188
FAX: (510) 741-6471 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Juliet Carrara
Regulatory Affairs/Quality Assurance Manager |
| Date of Summary Preparation: | March 10, 1999 |
| Device Name: | Microplate Neonatal GALT |
| Classification Name: | Class II, Galactose-1-phosphate uridyl transferase
test system; 21 CFR 862.1315, 75KQP |
| Unmodified Device: | RADIAS GALT Assay
K961432
Bio-Rad Laboratories
Hercules, CA 94547 |
| Statement of Intended Use: | This assay is for the qualitative determination of
galactose-1-phosphate uridyl transferase (GALT)
activity in dried blood spot samples.
Measurements of GALT are used in the diagnosis
and treatment of the hereditary disease galactosemia
(disorder of galactose metabolism) in infants.
For in vitro diagnostic use only. |
Description of Device
The Microplate Neonatal GALT assay utilizes dried blood spot samples (DBS) eluted in a medium containing 8-nicitinamide adenine dinucleotide phosphate (NADP), galactose-1phosphate, uridine-5-diphosphoglucose (UDPG), and a tetrazolium salt. During elution, GALT present in the specimen converts galactose-1-phosphate to glucose-1-phosphate, with the eventual reduction of NADP to NADPH.
1
After elution, an aliquot of the eluate is transferred to a microwell. The optical density (OD) is read, then Enzyme Reagent is added. During the incubation that follows, the Enzyme Reagent converts NADPH generated by GALT and endogenous red cell enzymes to NADP, and the tetrazolium salt to a colored formazan dye which is detected at 550 or 570 nm. The OD is read again and the difference between the two OD readings is determined. GALT activity, in units/g hemoglobin or units/liter blood, is calculated from the difference in signal between the two absorbance readings. A unit is defined as the quantity of GALT that catalyzes the formation of 1 micromole of UDP galactose per gram of hemoglobin or per Liter blood per hour at 37℃. An external calibrator is not necessary because enzyme activity is measured directly with substrates in excess.
RADIAS
Technical Characteristics Compared to Unmodified Device
The technical characteristics are summarized in the flow chart below:
Microplate
Manual Steps: Manual steps: Punch 1/8 inch DBS into microtiter well す Add 200 ul Substrate/Color Reagent + Incubate 3 Hrs at 37 C + + RADIAS steps: Mix and transfer 120 ul into clean wells + Read at 570 nm Read at 550 nm + Add 50 ul Enzyme Reagent → + Incubate 37 C, 10 min. + Read at 570 nm Read at 550 nm
Punch 3/16 inch DBS into 12 X 75 tubes Add 350 ul Substrate/Color Reagent Incubate 3 Hrs at 37 C Transfer 120 ul into clean wells Add 60 ul Enzyme Reagent Incubate 37 C, 20 min.
The main differences between the protocols are where the Microplate Neonatal GALT format uses 1/8 inch DBS in 200 ul Elution reagent rather than a 3/16 inch DBS in 350 ul elution reagent (RADIAS format). After 3 hours of elution the Microplate format continues processing the test in a manual mode whereas the RADIAS format completes the test by automation. No significant changes were made in the assay reagents or procedure.
5
2
Performance Characteristics
| Performance Tests | Acceptance Criteria | Microplate Assay | RADIAS Assay |
|---|---|---|---|
| Concordance | 100% | 100%(to RADIAS) | 100%(To Beutler) |
| Analytical Sensitivity |