GSP NEONATALGALT KIT, MODEL 3303-001U
Device Facts
| Record ID | K100101 |
|---|---|
| Device Name | GSP NEONATALGALT KIT, MODEL 3303-001U |
| Applicant | Perkinelmer, Inc. |
| Product Code | KQP · Clinical Chemistry |
| Decision Date | Jun 11, 2010 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1315 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
This kit (GSPTM Neonatal GALT) is intended for the quantitative determination of galactose-1-phosphate uridyl transferase (GALT) activity in blood specimens dried on filter paper as an aid in screening newborns for classical galactosemia caused by GALT deficiency using the GSPTM instrument.
Device Story
Quantitative fluoroimmunoassay for GALT activity in newborn dried blood spots (DBS). Input: DBS samples on filter paper cassettes. Process: Enzymatic reaction sequence (GALT, PGM, G6PD, 6-PGD) producing NADPH; prompt fluorescence measured at 355nm excitation/460nm emission. Output: Quantitative GALT activity (U/dL). Used in clinical laboratories on GSP instrument. Healthcare providers use results to identify presumptive positive cases for classical galactosemia, triggering follow-up diagnostic testing. Benefits: Early detection of galactosemia to prevent severe neonatal complications.
Clinical Evidence
Clinical comparison study performed in a routine screening laboratory with 2205 infants (2146 routine, 33 retrospective low GALT). Compared GSP Neonatal GALT to predicate NG-1100/4100. Overall percent agreement ranged from 98.9% to 99.6% depending on percentile cut-off (0.5th, 1.0th, 1.5th). Positive percent agreement ranged from 83.6% to 92.9%. Bench testing included precision (CLSI EP5-A2), linearity (EP6-A), detection limits (EP17-A), and interference/hematocrit effects (EP7-A2).
Technological Characteristics
Quantitative, time-resolved fluoroimmunoassay. Reagents: GALT substrate, assay buffer (magnesium sulfate, EDTA, Tris, Triton X-100). Calibrators/controls: sheep/human blood matrix. Detection: Prompt fluorescence (355nm ex/460nm em). Platform: GSP instrument. Software: GSP Workstation, linear regression fitting. Sterilization: Not applicable (reagents). Connectivity: GSP instrument-based.
Indications for Use
Indicated for quantitative determination of GALT activity in dried blood spot specimens to aid in screening newborns for classical galactosemia caused by GALT deficiency. For professional use only.
Regulatory Classification
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.
Predicate Devices
- PerkinElmer Neonatal GALT (formerly Isolab Galactose-1-phosphate uridyl transferase test kit) (k950803)
Related Devices
- K190335 — GSP Neonatal Total Galactose kit · Perkinelmer, Inc. · Nov 6, 2019
- K133652 — GSP NEONATAL TOTAL GALACTOSE KIT · Wallac Oy, A Subsidiary of Perkinelmer, Inc. · Apr 28, 2014
Submission Summary (Full Text)
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## 510(k) Summary
This summary of 510(k) safety and effectiveness information is supplied in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510 (k) number is K100101
Date: June 10, 2010
| Submitted by: | Wallac Oy, Division of PerkinElmer Inc.<br>Mustionkatu 6<br>20750 Turku, Finland | | | | |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Contact Person: | | | | | |
| Primary: | Kay A. Taylor<br>Tele: 317 418-1735<br>Fax: 317 536-3064 | | | | |
| Secondary: | Kati Suonpaa<br>Tele: (011) +358 2 2678 402<br>Fax: (011) +358-2-2678357 | | | | |
| Trade Name: | GSP Neonatal GALT kit (3303-001U) | | | | |
| Common Name:<br>Regulation: | GSP Neonatal GALT kit (21 CFR 862.1315) | | | | |
| Classification Name:<br>Product Code: | Galactose-1-phosphate uridyl transferase test system<br>(KQP) | | | | |
| Predicate device: | Neonatal GALT (formerly Isolab Galactose-1-Phosphate<br>Uridyl Tranferase test) (K950803) | | | | |
| Device Description: | The GSPTM Neonatal GALT assay is an adaptation of the<br>quantitative enzymatic assay of Beutler and Baluda. The<br>fluorescence is measured with the GSP Instrument using<br>an excitation wavelength of 355 nm and an emission<br>wavelength of 460 nm. The GSP Neonatal GALT assay<br>uses prompt fluorescence technology. | | | | |
| Intended Use: | This kit (GSPTM Neonatal GALT) is intended for the<br>quantitative determination of galactose-1-phosphate uridyl<br>transferase (GALT) activity in blood specimens dried on<br>filter paper as an aid in screening newborns for classical<br>galactosemia caused by GALT deficiency using the GSPTM<br>instrument. | | | | |
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## Device Comparison:
| GSP Neonatal GALT Test System | | |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Proposed Device | Neonatal GALT (K950803) |
| Intended<br>Use/Indications for<br>Use | This kit (GSP Neonatal GALT) is<br>intended for the quantitative<br>determination of galactose-1-<br>phosphate uridyl transferase<br>(GALT) activity in blood<br>specimens dried on filter paper as<br>an aid in screening newborns for<br>classical galactosemia caused by<br>GALT deficiency.using the<br>GSPTM instrument.<br><br>The GSP instrument and GSP<br>chemistries are for professional<br>use only. | This kit (Neonatal GALT) is<br>intended for the semi-quantitative<br>determination of galactose-1-<br>phosphate uridyl transferase<br>(GALT) activity in blood specimens<br>dried on filter paper as an aid in<br>screening newborns for classical<br>galactosemia caused by GALT<br>deficiency |
| Intended User | Same | Adequately trained laboratory<br>personnel performing newborn<br>screening |
| Instrument<br>Platform | GSP instrument | 1420 Victor D series fluorometer |
| Test Mode<br>Detection<br>Technology | Same<br>Same | Batch mode<br>Prompt fluorescence |
| Sample Type | Same | Dried blood spots. |
| Plate Capacity | 26 plates | 1 plate |
| Reagents | Individually bar-coded reagents | No bar-coded reagents |
| User Interface | GSP software -MicroSoft<br>Windows Vista embedded - touch<br>screen | Wallac 1420 D software running on<br>MicroSoft Windows XP<br>Professional |
| Instrument<br>Components | Instrument (consists of plate<br>manipulator and modules).<br>External PC<br>Barcode reader. | Instrument<br>Printer<br>Computer |
| Calibrators | Same | Six levels of GALT calibrators |
| Source | Same | Sheep blood with GALT,<br>phosphoglucomutase, glucose-6-<br>phosphate dehydrogenase and<br>dithiothreitol with ProClin 300 as<br>preservative. |
| Matrix | Filter paper cassettes<br>(Whatman no.903) | Filter paper sheets<br>(Whatman no. 903) |
| Concentrations | A 1 U/dL<br>B 3 U/ dL<br>C 6 U/dL<br>D 9 U/ dL<br>E 15 U/ dL | A 1.8 U/g Hb<br>B 5 U/g Hb<br>C 8 U/g Hb<br>D 11 U/g Hb<br>E 14 U/g Hb |
| Controls | Same | Two levels of GALT controls |
| Source | Human and sheep blood with<br>ProClin 300 as preservative | Sheep blood with GALT,<br>phosphoglucomutase, glucose-6-<br>phosphate dehydrogenase and<br>dithiothreitol with ProClin 300 as<br>preservative. |
| Matrix | Filter paper cassettes<br>(Whatman no.903) | Filter paper sheets<br>(Whatman no. 903) |
| Concentrations | Approx. values:<br>Low 4 U/dL<br>High 13 U/dL | Approx. values:<br>Normal 12.7 U/g Hb<br>Abnormal 2.1 U/g Hb |
| Substrate Reagent<br>Ingredients | Same | Contains beta-nicotinamide adenine<br>dinucleotide phosphate,uridine 5'-<br>diphosphoglucose, galactose-1-<br>phosphate, and dithiothreitol |
| Reconstitution<br>Buffer | Ready-for-use buffer contains<br>magnesium sulfate,<br>ethylenediaminetetraacetic acid,<br>tris aminomethane, Triton X-100,<br>and ProClin 300 as preservative. | Ready-for-use buffer contains<br>magnesium sulphate,<br>ethylenediaminetetraacetic acid, tri<br>aminomethane, and ProClin 300 as<br>preservative. |
| MicroPlates | Clear uncoated, sold separately | Black uncoated |
| Detection | Same | Defined by analyte specific protocol |
| Calculation | GSP Workstation software,<br>X-axis LIN, Y-axis LIN; fitting<br>algorithm linear regression | The system incorporates programs<br>for data reduction, and the results<br>obtained as printouts of calibration<br>curves, unknown activities etc. |
| Incubation Detail | 20 min + 2 hours, 37°C | 3 hours, 37°C and 60min, RT |
| Testing Integrity<br>Controls | Floating Disk Control - detects<br>floating sample disks in the wells before<br>measuring GALT activity<br>Elution Control - detects missing<br>sample disks in the wells after<br>measuring GALT activity | Not available |
Comparison of the GSP Neonatal GALT device with its predicate.
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## . Performance Characteristics
#### Precision:
Precision was determined in accordance with NCCLS (CLSI) document EP5-A2.
The variation of the GSP Neonatal GALT assay was determined using dried blood spot samples and controls, 3 kit lots, and 3 GSP instruments. The study was performed over 25 days in 27 runs each consisting of 2 plates with 4 replicates per sample. The analysis of variance approach was used to calculate the following:
| RESULTS | | | | | | | | |
|---------|------|---------------------------|----------------------|------|----------------------|------|-----------------|------|
| Sample | n | Mean GALT activity (U/dL) | Within run variation | | Within lot variation | | Total variation | |
| | | | SD | CV% | SD | CV% | SD | CV% |
| S1 | 209* | 2.5 | 0.3 | 10.3 | 0.4 | 14.3 | 0.4 | 15.9 |
| S2 | 216 | 3.1 | 0.3 | 8.6 | 0.4 | 12.6 | 0.4 | 13.1 |
| S3 | 206* | 3.9 | 0.2 | 6.1 | 0.3 | 8.3 | 0.3 | 8.6 |
| S4 | 216 | 5.3 | 0.3 | 5.7 | 0.5 | 9.0 | 0.5 | 9.2 |
| S5 | 216 | 7.1 | 0.3 | 3.8 | 0.5 | 7.4 | 0.5 | 7.6 |
| S6 | 216 | 13.1 | 0.9 | 6.7 | 1.2 | 8.9 | 1.2 | 9.1 |
| S7 | 216 | 18.3 | 0.6 | 3.1 | 0.9 | 5.1 | 1.0 | 5.4 |
| S8 | 216 | 22.5 | 0.7 | 3.0 | 1.1 | 4.9 | 1.2 | 5.2 |
Precision data using a full calibration curve on each plate:
* Some results have been excluded because of technical errors.
Precision data using one calibration curve valid for 24 h.
| RESULTS | | | | | | | | |
|---------|------|------------------------------------|-------------------------|------|-------------------------|------|-----------------|------|
| Sample | n | Mean<br>GALT<br>activity<br>(U/dL) | Within run<br>variation | | Within lot<br>variation | | Total variation | |
| | | | SD | CV% | SD | CV% | SD | CV% |
| S1 | 209* | 2.4 | 0.3 | 12.8 | 0.3 | 14.3 | 0.4 | 15.7 |
| S2 | 216 | 3.0 | 0.4 | 12.2 | 0.4 | 13.3 | 0.4 | 13.6 |
| S3 | 206* | 3.9 | 0.3 | 7.6 | 0.3 | 8.8 | 0.3 | 9.0 |
| S4 | 216 | 5.3 | 0.4 | 7.9 | 0.5 | 9.6 | 0.5 | 9.8 |
| S5 | 216 | 7.0 | 0.4 | 5.7 | 0.6 | 7.9 | 0.6 | 8.3 |
| S6 | 216 | 13.0 | 1.0 | 7.4 | 1.2 | 9.0 | 1.2 | 9.5 |
| S7 | 216 | 18.2 | 0.7 | 3.8 | 1.0 | 5.5 | 1.1 | 6.0 |
| S8 | 216 | 22.4 | 0.8 | 3.4 | 1.2 | 5.3 | 1.3 | 5.8 |
* Some results have been excluded because of technical errors.
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#### Linearity:
Linearity was determined in accordance with NCCLS document EP6-A.
For GALT activities over 4 U/dL, the maximum observed difference (%) between the linear and 3td order regression models is -2.6 %. For activities ≤ 4 U/dL, the maximum observed absolute difference between the models is 0.07 U/dL.
For GSP Neonatal GALT, the method has been demonstrated to be linear throughout the measuring range, from extends from 2.5 U/dL to 25 U/dL.
#### Detection Limit:
The limits of blank, detection and quantitation were determined in accordance with NCCL document EP17-A.
The Limit of Blank (LoB) for GSP Neonatal GALT kit is 1.6 U/dL, defined as the 95th percentile of a distribution of blank (GALT deficient) samples (n=83). The Limit of Detection (LoD) is 2.5 U/dL based on 351 determinations of five low level samples. The Limit of Quantitation (LoQ) is 2.5 U/dL, defined as the lowest activity with a total CV equal or less than 20% (n=209).
#### Analytical Specificity:
The GSP Neonatal GALT kit was evaluated for interference in accordance with CLSI document EP7-A2.
Whole blood with three different GALT activities (approximately 3, 6 and 12 U/dL) were enriched above the endogenous levels with possible interfering substances as presented below.
Icteric (unconjugated bilirubin (≤ 40 mg/dL blood), conjugated bilirubin (≤ 40 mg/dL blood)) and lipemic (Intralipid ≤ 1000 mg/dL blood) samples did not interfere with the assay. Ascorbic acid (≤ 3 mg/dL blood) and galactose (≤ 50 mg/dL blood) did not interfere with the assay at tested concentrations.
Glutathione did not interfere up to concentration of 18.8, 37.5 and 56.3 mg/dL blood at sample GALT activities of 3, 6 and 12 U/dL, respectively. Glutathione concentrations above these levels caused a decrease of up to 63% in GALT activity.
Galactose-1-phosphate (GAL-1-P) had no effect on the low GALT activity sample (3 U/dL), while a GAL-1-P concentration of 12.5 mg/dL blood interfered with the result of the samples with GALT activities 6 and 12 U/dL. The measured GALT result decreased up to 37%.
Total protein (HSA) had no effect on the high (12 U/dL) activity sample. HSA did not interfere up to added concentration of 3000 mg/dL blood, which is approximately two times higher than the normal endogenous concentration of normal neonates, at sample GALT activities 3 and 6 U/dL. Added HSA concentrations above this level caused an increase up to 30% in GALT activity.
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The effect of hematocrit was tested by adjusting the amount of red blood cells with plasma on three whole blood samples with different GALT activities (approximately <1, 6, and 15 U/dL), and testing the blood samples for GALT activity according to CLSI document EP7-A2. The results are shown below.
| Hematocrit %<br>(approximate value) | Sample 1 | | Sample 2 | | Sample 3 | |
|-------------------------------------|----------|------|----------|------|----------|------|
| | n | U/dL | n | U/dL | n | U/dL |
| 35 | 12 | 0.99 | 12 | 7.3 | 12 | 13.2 |
| 44 | 12 | 0.37 | 11 | 6.5 | 12 | 14.9 |
| 53 | 12 | 0.00 | 12 | 5.6 | 10 | 15.4 |
| 62 | 11 | 0.00 | 12 | 5.0 | 12 | 15.6 |
| 70 | 12 | 0.00 | 11 | 4.6 | 12 | 15.2 |
#### Effect of hematocrit
Samples with low GALT activity might get slightly elevated or lowered results from the GSP Neonatal GALT assay due to differences in the hematocrit level. GALT activity is in the red blood cells and hence the GALT activity varies based on hematocrit level. However, hemoglobin is known to absorb part of the excitation and emission light. In samples with normal GALT activity the change in hematocrit is compensated with the hemoglobin effect. In samples with low GALT activity there is not enough GALT activity to overcome the quenching effect of hemoglobin and thus the samples with low GALT activity and low hematocrit may result in elevated results and samples with low GALT activity and high hematocrit may result in lower results.
The differences in hematocrit level have no effect on the screening classification of samples with no GALT activity (classical galactosemia).
#### Comparison Studies:
The 3303-001U GSP Neonatal GALT kit was compared to the NG-1100/4100 Neonatal GALT kit in a routine screening laboratory by measuring the GALT activity in a total of 2205 infants. The specimens were routine (n = 2146) and retrospective low GALT activity (n = 33) screening specimens. A comparison of the routine screening samples is provided in the table below.
| Method | n | Range | Mean | Median | 0.5th<br>percentile | 1.0st<br>percentile | 1.5th<br>percentile |
|----------------------------|------|---------|------|--------|---------------------|---------------------|---------------------|
| GSP<br>3303-001U<br>(U/dL) | 2146 | 2.5–25* | 15.5 | 15.6 | 5.5 | 6.7 | 7.5 |
| NG-1100/4100<br>(U/g Hb) | 2146 | 3.0–18 | 10.2 | 10.2 | 5.1 | 5.7 | 6.1 |
* Samples that resulted in values below 2.5 U/dL were reported as "<2.5 U/dL" and samples that resulted in values above 25 U/dL were reported as ">25 U/dL"
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### Screening Performance
Cut-off values based on the 0.5th, 1.05, and 1.5th percentiles were used for both methods.
Samples that resulted in values below 2.5 U/dL were reported as"<2.5 U/dL" and considered screen positive for classical galactosemia. Samples that resulted in values above 25 U/dL were reported as'>25 U/dL" and considered screen negative for classical galactosemia.
Please note that the cut-off values used in this section only apply to this study. If the measured median GALT activity of routine samples is lower than the values given in this section, a higher percentile should be used to determine the cut-off (see sections "SPECIMEN COLLECTION AND HANDLING" and "EXPECTED VALUES AND INTERPRETATION OF RESULTS").
| Neonatal<br>GALT kit | NG-1100/4100 | | |
|----------------------|---------------|---------------|-------|
| GSP 3303-001U | Test Positive | Test Negative | Total |
| Test Positive | 39* | 5 | 44 |
| Test Negative | 3 | 2132 | 2135 |
| Total | 42 | 2137 | 2179 |
Screening performance using the 0.5th percentile
* Includes all 33 retrospective low GALT activity screening specimens
Overall percent agreement = (39 + 2132) / (2179)* 100% = 99.6% (CI 99.3%-99.9%) Positive percent agreement = (39 / 42)* 100% = 92.9% (CI 83.9%-100%) Negative percent agreement = (2132 / 2137)*100% = 99.8% (CI 99.5%-100%)
| Screening performance using the 1.0st percentile. | | |
|---------------------------------------------------|--|--|
| | | |
| Neonatal<br>GALT kit | NG-1100/4100 | | |
|----------------------|---------------|---------------|-------|
| GSP 3303-001U | Test Positive | Test Negative | Total |
| Test Positive | 45* | 8 | 53 |
| Test Negative | 8 | 2118 | 2126 |
| Total | 53 | 2126 | 2179 |
* Includes all 33 retrospective low GALT activity screening specimens
Overall percent agreement = (45 + 2118) / (2179)* 100% = 99.3% (CI 98.9%--99.7%) Positive percent agreement = (45 / 53)* 100% = 84. 9% (CI 74.3%-95.5%) Negative percent agreement = (2118 / 2126)*100% = 99.6% (CI 99.3%--99.9%)
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Screening performance using the 1.5th percentile
| Neonatal<br>GALT kit | NG-1100/4100 | | |
|----------------------|---------------|---------------|-------|
| GSP 3303-001U | Test Positive | Test Negative | Total |
| Test Positive | 51* | 14 | 65 |
| Test Negative | 10 | 2104 | 2114 |
| Total | 61 | 2118 | 2179 |
* Includes all 33 retrospective low GALT activity screening specimens
Overall percent agreement = (51 + 2104) / (2179)* 100% = 98.9% (CI 98.4%-99.4%) Positive percent agreement = (51 / 61)* 100% = 83.6% (CI 73.5%-93.7%) Negative percent agreement = (2104 / 2118)*100% = 99.3% (CI 99.0%-99.7%)
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Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
## DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
PerkinElmer, Inc. c/o Ms. Kay A. Taylor Director, Regulatory and Clinical Affairs 8275 Carloway Road Indianapolis, IN 46236
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
# JUN 1 1 2010
k100101 Trade/Device Name: GSP Neonatal GALT kit Regulation Number: 21 CFR § 862.1315 Regulation Name: Galactose-1-phosphate uridyl transferase test system Regulatory Class: Class II Product Code: KQP Dated: April 28, 2010 Received: April 30, 2010
Dear Ms. Taylor:
Re:
We have reviewed your Section 510(k) premarket.notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of medical devicerelated adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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#### Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 80) , please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to (201) . For part 807.97). For questions regarding regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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# Indications for Use Form
510(k) Number (if known): K100101
Device Name: GSP Neonatal GALT
Indications for Use:
The GSP Neonatal GALT kit is intended for the quantitative determination of r ne Sose - 1-phosphate uridyl transferase (GALT) activity in blood specimens dried on filter paper as an aid in screening newborns for classical galactosemia caused by GALT deficiency using the GSP™ instrument.
Prescription Use XXXX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K100101
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