(149 days)
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.
The GSPTM Neonatal GALT assay is an adaptation of the quantitative enzymatic assay of Beutler and Baluda. The fluorescence is measured with the GSP Instrument using an excitation wavelength of 355 nm and an emission wavelength of 460 nm. The GSP Neonatal GALT assay uses prompt fluorescence technology.
Here's a breakdown of the acceptance criteria and study information for the GSP Neonatal GALT kit, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The provided document does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for precision, linearity, detection limits, or agreement with the predicate device. Instead, it presents the results of these performance characteristics studies and a comparison with the predicate device.
However, based on the intent of the comparison study with the predicate device, we can infer some implicit acceptance goals relating to agreement with the established method. The screening performance tables directly compare the classification of samples between the new device and the predicate.
Inferred Acceptance Criteria & Reported Device Performance:
| Performance Metric | Inferred Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision (CV%) | Values within acceptable clinical laboratory ranges for quantitative assays, typically demonstrating good reproducibility. (Specific quantitative targets for CV% are not stated, but results are presented to demonstrate low variability across multiple conditions.) | Within-Run Variation: CV% range from 3.0% to 12.8%Within-Lot Variation: CV% range from 4.9% to 14.3%Total Variation: CV% range from 5.2% to 15.9% |
| Linearity | Demonstrated linearity across the expected measuring range for clinical utility. | Linear throughout the measuring range of 2.5 U/dL to 25 U/dL. Maximum observed difference between linear and 3rd order regression models is -2.6% for GALT activities >4 U/dL, and max absolute difference of 0.07 U/dL for GALT activities ≤ 4 U/dL. |
| Detection Limit (LoQ) | Ability to accurately quantify GALT activity at low concentrations relevant for screening GALT deficiency. | LoB: 1.6 U/dLLoD: 2.5 U/dLLoQ: 2.5 U/dL (with total CV ≤ 20%) |
| Analytical Specificity | No significant interference from common endogenous substances or therapeutic compounds (e.g., icteric, lipemic samples, ascorbic acid, galactose). Minimal or explainable interference from other relevant substances (e.g., glutathione, GAL-1-P) at clinically relevant concentrations. | No interference from icteric (bilirubin ≤ 40 mg/dL), lipemic (Intralipid ≤ 1000 mg/dL), ascorbic acid (≤ 3 mg/dL), or galactose (≤ 50 mg/dL). Glutathione: Interference (decrease up to 63%) above 18.8, 37.5, 56.3 mg/dL at 3, 6, 12 U/dL GALT activity respectively.GAL-1-P: No effect on 3 U/dL samples; interference (decrease up to 37%) on 6 and 12 U/dL samples at 12.5 mg/dL.Total protein (HSA): No effect on 12 U/dL samples; interference (increase up to 30%) on 3 and 6 U/dL samples above 3000 mg/dL. |
| Comparison with Predicate - Screening Performance (using 0.5th percentile cut-off) | High overall agreement, positive percent agreement, and negative percent agreement with the predicate device (NG-1100/4100), demonstrating comparable screening classification. | Overall percent agreement: 99.6% (CI 99.3%-99.9%)Positive percent agreement: 92.9% (CI 83.9%-100%)Negative percent agreement: 99.8% (CI 99.5%-100%) |
| Comparison with Predicate - Screening Performance (using 1.0st percentile cut-off) | Similarly high agreement metrics at a different cut-off. | Overall percent agreement: 99.3% (CI 98.9%-99.7%)Positive percent agreement: 84.9% (CI 74.3%-95.5%)Negative percent agreement: 99.6% (CI 99.3%-99.9%) |
| Comparison with Predicate - Screening Performance (using 1.5th percentile cut-off) | Similarly high agreement metrics at a different cut-off. | Overall percent agreement: 98.9% (CI 98.4%-99.4%)Positive percent agreement: 83.6% (CI 73.5%-93.7%)Negative percent agreement: 99.3% (CI 99.0%-99.7%) |
Study Information
-
Sample size used for the test set and the data provenance:
- Precision Study: 8 samples (S1-S8), each tested with 206-216 replicates (n values).
- Detection Limit Study:
- LoB: 83 GALT deficient samples
- LoD: 351 determinations of five low-level samples
- LoQ: 209 replicates
- Analytical Specificity Study: Whole blood samples with three different GALT activities (approx. 3, 6, and 12 U/dL) were tested. Hematocrit effect was tested on three whole blood samples (approx. <1, 6, and 15 U/dL). Number of replicates (n) for hematocrit testing ranged from 10 to 12 for each hematocrit level.
- Comparison Studies (Screening Performance): A total of 2205 infants.
- Routine screening specimens: 2146 samples.
- Retrospective low GALT activity specimens: 33 samples.
- Data Provenance: Not explicitly stated, but the comparison study was performed "in a routine screening laboratory," implying real-world clinical samples. The study does not specify the country of origin, but the submission is from Finland with a US contact, suggesting potential international collaboration or a study done in a US lab, though this is not definitively stated. The use of "routine" and "retrospective" specimens indicates it's a mix of prospective (routine) and retrospective (low GALT activity) data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- The ground truth for the comparison study was established by the predicate device (NG-1100/4100 Neonatal GALT kit). Therefore, no human experts were involved in establishing the ground truth for the comparison study. For the underlying clinical truth, the predicate device's performance would have been validated against clinical outcomes or confirmed diagnoses (e.g., pathology, genetic testing), but this information is not provided for the predicate device within this summary.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The ground truth was based on the measurement from the predicate device, not on expert adjudication.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a medical device for quantitative determination of a biomarker, not an AI-assisted diagnostic imaging or interpretation system requiring human readers.
-
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
- Yes, the performance characteristics (precision, linearity, detection limit, analytical specificity) and the comparison study represent the standalone performance of the GSP Neonatal GALT kit (algorithm only). The device's intended use is for quantitative determination using the GSP instrument, which is an automated process without direct human-in-the-loop interpretation that would alter the quantitative result provided by the device. The "screening performance" discussed refers to the device's ability to classify samples based on its quantitative output and a defined cut-off, not a human-AI interaction.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the comparison study, the "ground truth" (or reference standard) was the predicate device (NG-1100/4100 Neonatal GALT kit). The predicate device's classifications were used to assess the agreement of the new device. For the analytical studies, the ground truth was based on known concentrations or properties of the samples used (e.g., GALT deficient samples for LoB, known GALT activities for linearity and specificity).
-
The sample size for the training set:
- Not applicable. This device is a diagnostic assay kit, not an AI/machine learning model that typically requires a distinct "training set." The performance characteristics and comparison studies are conducted on test sets to validate the device's analytical performance.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set in the context of an AI/machine learning model. For the assay, the "ground truth" in development would refer to the standards and controls used to establish the assay's biochemical principles and calibrate its measurements.
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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.Mustionkatu 620750 Turku, Finland | ||||
|---|---|---|---|---|---|
| Contact Person: | |||||
| Primary: | Kay A. TaylorTele: 317 418-1735Fax: 317 536-3064 | ||||
| Secondary: | Kati SuonpaaTele: (011) +358 2 2678 402Fax: (011) +358-2-2678357 | ||||
| Trade Name: | GSP Neonatal GALT kit (3303-001U) | ||||
| Common Name:Regulation: | GSP Neonatal GALT kit (21 CFR 862.1315) | ||||
| Classification Name:Product Code: | Galactose-1-phosphate uridyl transferase test system(KQP) | ||||
| Predicate device: | Neonatal GALT (formerly Isolab Galactose-1-PhosphateUridyl Tranferase test) (K950803) | ||||
| Device Description: | The GSPTM Neonatal GALT assay is an adaptation of thequantitative enzymatic assay of Beutler and Baluda. Thefluorescence is measured with the GSP Instrument usingan excitation wavelength of 355 nm and an emissionwavelength of 460 nm. The GSP Neonatal GALT assayuses prompt fluorescence technology. | ||||
| Intended Use: | This kit (GSPTM Neonatal GALT) is intended for thequantitative determination of galactose-1-phosphate uridyltransferase (GALT) activity in blood specimens dried onfilter paper as an aid in screening newborns for classicalgalactosemia caused by GALT deficiency using the GSPTMinstrument. |
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Device Comparison:
| GSP Neonatal GALT Test System | ||
|---|---|---|
| Characteristics | Proposed Device | Neonatal GALT (K950803) |
| IntendedUse/Indications forUse | This kit (GSP Neonatal GALT) isintended for the quantitativedetermination of galactose-1-phosphate uridyl transferase(GALT) activity in bloodspecimens dried on filter paper asan aid in screening newborns forclassical galactosemia caused byGALT deficiency.using theGSPTM instrument.The GSP instrument and GSPchemistries are for professionaluse only. | This kit (Neonatal GALT) isintended for the semi-quantitativedetermination of galactose-1-phosphate uridyl transferase(GALT) activity in blood specimensdried on filter paper as an aid inscreening newborns for classicalgalactosemia caused by GALTdeficiency |
| Intended User | Same | Adequately trained laboratorypersonnel performing newbornscreening |
| InstrumentPlatform | GSP instrument | 1420 Victor D series fluorometer |
| Test ModeDetectionTechnology | SameSame | Batch modePrompt 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 -MicroSoftWindows Vista embedded - touchscreen | Wallac 1420 D software running onMicroSoft Windows XPProfessional |
| InstrumentComponents | Instrument (consists of platemanipulator and modules).External PCBarcode reader. | InstrumentPrinterComputer |
| Calibrators | Same | Six levels of GALT calibrators |
| Source | Same | Sheep blood with GALT,phosphoglucomutase, glucose-6-phosphate dehydrogenase anddithiothreitol with ProClin 300 aspreservative. |
| Matrix | Filter paper cassettes(Whatman no.903) | Filter paper sheets(Whatman no. 903) |
| Concentrations | A 1 U/dLB 3 U/ dLC 6 U/dLD 9 U/ dLE 15 U/ dL | A 1.8 U/g HbB 5 U/g HbC 8 U/g HbD 11 U/g HbE 14 U/g Hb |
| Controls | Same | Two levels of GALT controls |
| Source | Human and sheep blood withProClin 300 as preservative | Sheep blood with GALT,phosphoglucomutase, glucose-6-phosphate dehydrogenase anddithiothreitol with ProClin 300 aspreservative. |
| Matrix | Filter paper cassettes(Whatman no.903) | Filter paper sheets(Whatman no. 903) |
| Concentrations | Approx. values:Low 4 U/dLHigh 13 U/dL | Approx. values:Normal 12.7 U/g HbAbnormal 2.1 U/g Hb |
| Substrate ReagentIngredients | Same | Contains beta-nicotinamide adeninedinucleotide phosphate,uridine 5'-diphosphoglucose, galactose-1-phosphate, and dithiothreitol |
| ReconstitutionBuffer | Ready-for-use buffer containsmagnesium sulfate,ethylenediaminetetraacetic acid,tris aminomethane, Triton X-100,and ProClin 300 as preservative. | Ready-for-use buffer containsmagnesium sulphate,ethylenediaminetetraacetic acid, triaminomethane, and ProClin 300 aspreservative. |
| MicroPlates | Clear uncoated, sold separately | Black uncoated |
| Detection | Same | Defined by analyte specific protocol |
| Calculation | GSP Workstation software,X-axis LIN, Y-axis LIN; fittingalgorithm linear regression | The system incorporates programsfor data reduction, and the resultsobtained as printouts of calibrationcurves, unknown activities etc. |
| Incubation Detail | 20 min + 2 hours, 37°C | 3 hours, 37°C and 60min, RT |
| Testing IntegrityControls | Floating Disk Control - detectsfloating sample disks in the wells beforemeasuring GALT activityElution Control - detects missingsample disks in the wells aftermeasuring GALT activity | Not available |
Comparison of the GSP Neonatal GALT device with its predicate.
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.
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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 | MeanGALTactivity(U/dL) | Within runvariation | Within lotvariation | 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 %(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 | 0.5thpercentile | 1.0stpercentile | 1.5thpercentile |
|---|---|---|---|---|---|---|---|
| GSP3303-001U(U/dL) | 2146 | 2.5–25* | 15.5 | 15.6 | 5.5 | 6.7 | 7.5 |
| NG-1100/4100(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").
| NeonatalGALT 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. | ||
|---|---|---|
| NeonatalGALT 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
| NeonatalGALT 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
Page 1 of 1
§ 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.