This kit is intended for the quantitative determination of human thyroid stimulating hormone (hTSH) in blood specimens dried on filter paper as an aid in screening newborns for congenital (neonatal) hypothyroidism using the GSP instrument.
The GSPTM Instrument is a fully automated, high throughput batch analyzer for time resolved analysis of samples in microtitration plates. It is in intended for in vitro quantitative / qualitative determination of analytes in body fluids.

Device Description

The GSP instrument (genetic screening processor) is a fully automated, high throughput batch analyzer for timeresolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative and qualitative determination of analytes in body fluids. The GSP instrument and GSP chemistries are for professional use only.
The GSPTM Neonatal hTSH assay is a solid phase, twosite fluoroimmunometric assay based on the direct sandwich technique in which two monoclonal antibodies (derived from mice) are directed against two separate antigenic determinants on the hTSH molecule. Calibrators, controls and test specimens containing hTSH are reacted simultaneously with immobilized monoclonal antibodies directed against a specific antigenic site on the ß hTSH subunit and europium-labeled monoclonal antibodies (directed against a different antigenic site located partly on the B subunit and partly on the a subunit) in assay buffer. The assay buffer elutes hTSH from the dried blood spots on the filter paper disks. The complete assay requires only one incubation step.
DELFIA Inducer dissociates europium ions from the labeled antibody into solution where they form highly fluorescent chelates with components of DELFIA Inducer. The fluorescence in each well is then measured. The fluorescence of each sample is proportional to the concentration of hTSH in the sample.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the GSP Neonatal hTSH kit, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Precision (TSH)	"Total variation (% CV)" should be acceptably low for assay use.	Using full calibration curve on each plate:- Sample 1 (10.5 µU/mL): 10.1% CV- Sample 2 (23.2 µU/mL): 8.9% CV- Sample 3 (102 µU/mL): 8.5% CV- Sample 4 (241 µU/mL): 8.7% CVUsing one calibration curve valid for 24h:- Sample 1 (10.6 µU/mL): 9.9% CV- Sample 2 (23.4 µU/mL): 8.3% CV- Sample 3 (102 µU/mL): 7.7% CV- Sample 4 (241 µU/mL): 7.9% CV
Linearity (TSH)	Should be linear across the intended reportable range.	Linear from 0.66 uU/mL to 375 uU/mL blood.
Limit of Blank (LoB)	Acceptably low to distinguish from blank.	0.96 uU/mL blood.
Limit of Detection (LoD)	Acceptably low for clinical application.	1.31 uU/mL blood.
Limit of Quantitation (LoQ)	Lowest concentration with total CV < 20%.	1.31 uU/mL blood (with total CV < 20%).
Analytical Specificity	No significant interference from common interferents or cross-reactants.	No interference from icteric, lipemic, or high hemoglobin samples. Minimal to no cross-reactivity with hFSH, hLH, and hCG at high concentrations.
Method Comparison (Overall Agreement)	Good agreement (>95-97%) with predicate device.	Site 1: 98.4% (95% CI: 97.9%-99.0%)Site 2: 98.4% (95% CI: 97.8%-98.9%)
Method Comparison (Positive Agreement)	Good agreement (>70%) for positive samples with predicate device.	Site 1: 75.9% (95% CI: 66.1%-85.7%)Site 2: 75.3% (95% CI: 66.0%-84.6%)
Method Comparison (Negative Agreement)	Good agreement (>98-99%) for negative samples with predicate device.	Site 1: 99.4% (95% CI: 99.0%-99.8%)Site 2: 99.5% (95% CI: 99.1%-99.8%)
Internal Method Comparison (Deming Regression)	Slope near 1, intercept near 0, demonstrating good correlation.	Slope: 0.97 (95% CI: 0.94, 1.01)Intercept: -0.21 (95% CI: -0.37, -0.16)

Note: The document provides specific performance results but often implies the acceptance criteria through the presentation of these results in the context of predicate device comparison and clinical guidelines (e.g., AAP recommendations for TSH cut-offs).

2. Sample Sizes Used for the Test Set and Data Provenance

Precision Study:
- Sample Size: 4 spiked dry whole blood spot samples, run over 23 days in 27 runs, each consisting of 2 plates with 4 replicates per sample. (Specific total number of individual measurements for precision across all samples is not explicitly stated but is substantial: 4 samples * 27 runs * 2 plates * 4 replicates = 864 individual measurements.)
- Data Provenance: The document does not specify the country of origin for these spiked samples. It is implied to be laboratory-generated per NCCLS (CLSI) guidelines. Retrospective or prospective is not specified, but typically, these are prospective internal lab studies.
Detection Limit Study:
- LoB Sample Size: 216 blank samples.
- LoD Sample Size: 432 determinations (72 blank and 216 low-level samples included).
- Data Provenance: Not specified, but implied to be prospective internal lab studies following CLSI guidelines.
Analytical Specificity (Cross-reactivity) Study:
- Sample Size: Not explicitly stated how many individual samples were used for each interferent, but presented for two different hTSH concentrations for each cross-reactant (hFSH, hLH, hCG).
- Data Provenance: Not specified, likely prospective internal lab studies.
Comparison Studies (Site 1 & Site 2):
- Site 1 Test Set Sample Size: 2053 samples (total). 20 diagnosed positive samples.
- Site 2 Test Set Sample Size: 2104 samples (total). 26 known positive samples.
- Data Provenance: Not explicitly stated, but these are likely clinical samples from the sites where the studies were performed. The terms "routine screening and spiked blood spot samples" are used in the Internal Method Comparison, suggesting a mix, but for Site 1 and Site 2 comparisons, they appear to be real-world samples. Retrospective or prospective is not specified, but comparison studies like this often use retrospective collections or samples run in a prospective manner against a standard.
Internal Method Comparison:
- Sample Size: N=162 samples.
- Data Provenance: "routine screening and spiked blood spot samples". Not specified by country.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

No information is provided regarding the number or qualifications of experts used to establish ground truth for the test set.
For the comparison studies, "diagnosed positive samples" and "known positive samples" are mentioned, suggesting a clinical diagnosis as the implicit ground truth, but the method of diagnosis is not detailed, nor are the experts involved.

4. Adjudication Method for the Test Set

No adjudication method is described. The comparison studies simply compare the GSP device's classification with that of the predicate device. For "diagnosed positive samples," the diagnosis itself serves as a form of ground truth, but how conflicting diagnoses (if any) were resolved is not stated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) test, not an image-reading or human-interpretation device. The studies described focus on the analytical performance of the instrument and kit, and its agreement with a predicate IVD device. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, the studies presented are all standalone (algorithm only) performance. The GSP Instrument and GSP Neonatal hTSH kit are automated systems for quantitative determination of hTSH. The results are generated directly by the instrument and its associated software/algorithm, without human interpretation as part of the primary measurement. Human users operate the instrument, but their "reading" of the result is simply recording the quantitative value provided by the system.

7. The Type of Ground Truth Used

For the Precision, Linearity, Detection Limit, and Analytical Specificity studies:
- The ground truth is reference values based on known dilutions or spiked concentrations in samples, following recognized laboratory standards (e.g., CLSI documents).
For the Comparison Studies (Site 1 & Site 2) and Internal Method Comparison:
- The ground truth is primarily based on the results obtained from the predicate device (AutoDELFIA Neonatal hTSH kit), which is an already legally marketed and established method for hTSH screening.
- Additionally, for a subset of samples, "diagnosed positive samples" or "known positive samples" are mentioned, implying clinical diagnosis of congenital hypothyroidism (likely based on follow-up and confirmatory tests) served as a form of clinical ground truth for these specific cases.

8. The Sample Size for the Training Set

No information is provided about a specific "training set" for the GSP Neonatal hTSH kit or instrument. This is typical for traditional IVD assays, which are developed and validated using analytical methods and comparison to established predicate devices, rather than machine learning algorithms that require distinct training and test sets in the same way. The development and optimization of the assay would involve various experiments, but these are not typically referred to as a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

As a specific "training set" is not mentioned in the context of an AI/ML algorithm development, this question is not applicable based on the provided document. The development of such an IVD kit involves extensive analytical characterization and optimization, but not in the framework of machine learning training data.

Summary

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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 K090846

SEP - 8 2009

Date: September 2, 2009

Submitted by:

Wallac Ov. Division of PerkinElmer Inc. Mustionkatu 6 20750 Turku, Finland

Contact Person: Primary:

Secondary:

Trade Name:

Common Name: Regulation:

Classification Name: Product Code:

Predicate device:

Device Description:

Kay A. Taylor Tele: 317 418-1735 Fax: 317 536-3064

Raija Koskivaara Tele: (011) +358-2-2678111 Fax: (011) +358-2-2678357

GSP Instrument GSP Neonatal hTSH kit (3301-0010)

GSP Instrument (21 CFR 862.2560) GSP Neonatal hTSH kit (21 CFR 862.1690)

Fluorometer for clinical use (KHO) Thyroid stimulating hormone radioimmunoassay (JLW)

AutoDELFIA instrument (K935047) AutoDELFIA Neonatal hTSH kit (K905710)

The GSPTM Neonatal hTSH assay is a solid phase, twosite fluoroimmunometric assay based on the direct sandwich technique in which two monoclonal antibodies (derived from mice) are directed against two separate antigenic determinants on the hTSH molecule. Calibrators, controls and test specimens containing hTSH are reacted simultaneously with immobilized monoclonal antibodies

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directed against a specific antigenic site on the ß hTSH subunit and europium-labeled monoclonal antibodies (directed against a different antigenic site located partly on the B subunit and partly on the a subunit) in assay buffer. The assay buffer elutes hTSH from the dried blood spots on the filter paper disks. The complete assay requires only one incubation step.

DELFIA Inducer dissociates europium ions from the labeled antibody into solution where they form highly fluorescent chelates with components of DELFIA Inducer. The fluorescence in each well is then measured. The fluorescence of each sample is proportional to the concentration of hTSH in the sample.

The GSP™ instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The GSP instrument and GSP chemistries are for professional use only.

This kit (GSP™ Neonatal hTSH) is intended for the quantitative determination of human thyroid stimulating hormone (hTSH) in blood specimens dried on filter paper as an aid in screening newborns for congenital (neonatal) hypothyroidism using the GSP instrument.

Device Comparison:

Comparison of the GSP Instrument and GSP Neonatal hTSH devices with their respective predicates.

GSP Instrument
Characteristics	Proposed Device	AutoDELFIA Instrument(K935047)
IntendedUse/Indications forUse	The GSPT™ instrument is a fullyautomated, high throughput batchanalyzer for time resolvedanalysis of samples inmicrotitration plates. It isintended for in vitro quantitative /qualitative determination ofanalytes in body fluids. The GSPinstrument and GSP chemistriesare for professional use only.	The Wallac 1235 AutoDELFIAautomatic immunoassay system isdesigned to automatically performassays using the DELFIAtechnology. DELFIA is based onthe proven and widely used methodof time-resolved fluorometry.
Intended User	Same	Adequately trained laboratorypersonnel performing newbornscreening
Test Mode	Same	Batch mode
DetectionTechnology	Same	Time-resolved fluoroimmunoassay
Sample Type	Dried blood spots	Dried blood spots, serum, plasma
Plate Capacity	24 plates	12 plates
Reagents	Individually bar-coded reagents	Reagent information on separatebarcode labels
User Interface	GSP software -MicroSoftWindows Vista embedded - touchscreen	AutoDELFIA Workstation software(MicroSoft Windows - resides onexternal PC - keyboard, mouse
InstrumentComponents	Instrument (consists of platemanipulator and modules).External PCBarcode reader.	Sample processorPlate processorExternal PC
	GSP Neonatal hTSH kit
Characteristics	Proposed Device	AutoDELFIA Neonatal hTSH kit
		(K905710)

Technology	Same	Time-resolved fluorescence
Sample Type	Same	Newborn Blood spot specimens
Calibrators	Same	Six levels of hTSH calibrators
Source	Same	Human whole blood with ahematocrit value of 50-55%
	Filter paper cassettes (Whatman	Filter paper sheets
Matrix	no.903)	(Whatman no. 903)
Concentrations	Same	A 1 µU/mL bloodB 10 µU/mL bloodC 25 µU/mL bloodD 50 µU/mL bloodE 100 µU/mL bloodF 250 µU/mL blood
Controls	Same	Two levels of hTSH controls
Source	Same	Human whole blood with ahematocrit value of 50-55%
Matrix	Filter paper cassettes (Whatmanno.903)	Filter paper sheets(Whatman no. 903)
Concentrations	Same	Approx. values:C1 15 µU/mL bloodC2 60 µU/mL blood
Tracer	Anti-h-TSH-Eu solution (~5µg/mL); 3vials, 2.8 mL	Anti-h-TSH-Eu stock solution (~20µg/mL); 6vials, 1.1 mL
	The tracer is Eu-N3-labeledantibody (clone 5409)	The tracer is Eu-N1-labeledantibody (clone 5403)
Assay Buffer	Same	Neo hTSH Assay Buffer3 bottles, 120 mL
Plates	Anti-hTSH Microtitration Strips(Nunc); 12 plates	Anti-hTSH Microtitration Strips(Thermo Electron); 12 plates
Detection	Same	Defined by analyte specific protocol
	X-axis LIN, Y-axis LIN; fittingalgorithm spline smoothed	fitting algorithm spline smoothed
Incubation Detail	3,5 hours, 25°C	5 hours, 25°C

Intended Use:

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Analytical Performance Characteristics

Precision:

TSH:

Precision was determined in accordance with NCCLS (CLSI) document EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods: Approved Guideline - Second Edition.

The variation of the 3301-0010 GSP Neonatal hTSH assay was determined using spiked dry whole blood spot samples, 3 kit lots and 3 GSP systems. The study was performed over 23 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:

Precision data using a full calibration curve on each plate:

Sample	Total meanvalue µU/mLblood	Within-runvariation(% CV)	Within-lotvariation(% CV)	Totalvariation(% CV)
1	10.5	6.8	8.9	10.1
2	23.2	5.9	8.6	8.9
3	102	6.1	8.3	8.5
4	241	6.4	8.4	8.7

Precision data using one calibration curve valid for 24 h:

Sample	Total meanvalue µU/mLblood	Within-runvariation(% CV)	Within-lotvariation(% CV)	Totalvariation(% CV)
1	10.6	7.0	8.7	9.9
2	23.4	6.1	8.0	8.3
3	102	6.2	7.7	7.7
4	241	6.8	7.7	7.9

Linearity:

TSH:

Linearity was determined in accordance with NCCLS (CLSI) document EP6-A, Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach, Approved Guideline. For hTSH, the method has been demonstrated to be linear from 0.66 uU/mL to 375 uU/mL blood.

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Detection Limit:

TSH:

The limits of blank, detection and quantitation were determined in accordance with NCCLS (CLSI) document EP17-A, Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline.

The Limit of Blank (LoB) for GSP neonatal hTSH kit is 0.96 uU/mL blood, defined as the 95th percentile of a distribution of blank samples (n=216). The Limit of Detection (LoD) is 1.31 uU/mL blood based on 432 determinations, 72 blank and 216 low level samples. The Limit of Quantitation (LoQ) is 1.31 uU/mL blood, defined as the lowest concentration with a total CV <20%.

Analytical Specificity:

TSH:

Icteric (unconjugated bilirubin ≤ 342 umol/L, equivalent to 20 mg/dL in blood, and conjugated bilirubin ≤ 237 umo½L. equivalent to 20 mg/dL in blood) samples do not interfere with the assay. Lipemic samples (Intralipid ≤ 10 mg/mL in blood) do not interfere with the assay. Additional hemoglobin up to 15 g/L does not interfere with the assay.

Cross reactivity was determined in accordance with CLSI document EP7-A2, Interference Testing in Clinical Chemistry: Approved Guideline - Second Edition.

For the GSP Neonatal hTSH kit, the cross reactivity with other substances is presented in the following table:

Antigen	Addedconcentration	Measured apparentTSH concentration(\u03BCU/mL blood)	Measured TSHconcentration withoutinterferent(\u03BCU/mL blood)
hFSH	0.25 U/mL	19.2	18.7
hFSH	0.25 U/mL	30.3	30.1
hLH	0.25 U/mL	16.2	15.4
hLH	0.25 U/mL	30.3	30.7
hCG	100 U/mL	14.5	15.5
hCG	100 U/mL	28.3	28.8

Comparison Studies:

TSH:

Samples were categorized in accordance with the cut-off recommendations for TSH measurements found in the 2006 Update of Newborn Screening and Therapy of Congenital Hypothyroidism by the American Academy of Pediatrics (AAP).

Site 1:

The table below shows the distribution into the test results categories for the GSP and predicate assays separately.

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hTSH	Normal(<20µU/mLserum)	Borderline(20-40 µU/mLserum)	Hypothyroid(>40µU/mL serum)
GSP	1978	53	22
Predicate	1970	61	22

Distribution of samples into test results categories

Of the diagnosed positive samples (n=20) both the GSP and predicate classified all samples as hypothyroid as can be seen in the table below.

Classification of diagnosed positive samples

Classification ofdiagnosed positivesamples	Normal(<20µU/mLserum)	Hypothyroid(>40µU/mL serum)
GSP	0	20
Predicate	0	20

The following table shows how the GSP and predicate have classified the same samples. It can be seen from the table some samples are exchanged between the borderline and normal samples but both methods classify the same samples as hypothyroid.

hTSH	GSP	Normal	Borderline	Hypothyroid
Normal	1958	20	0	1978
Borderline	12	41	0	53
Hypothyroid	0	0	22	22
Total	1970	61	22	2053

Distribution of samples into test results categories: GSP vs predicate

The overall percent agreement, the positive agreement and negative agreement are calculated along with 95% confidence intervals (95% CI). Results are presented in the table below and they show good agreement between methods.

The overall percent agreement, positive agreement and negative agreement

Numerator	Denominator	PercentAgreement*	95%CI*
Overall percentagreement	1958+41+22	2053	98.4%	97.9%-99.0%
Positiveagreement	41+22	61+22	75.9%	66.1%-85.7%
Negativeagreement	1958	1970	99.4%	99.0%-99.8%

In these calculations the borderline results are considered as positive.

Site 2:

The table below shows the distribution into the test results categories for the GSP and predicate assays separately.

Distribution of samples into test results categories

hTSH	Normal( $ <20µU/mL$serum)	Borderline(20-40 $µU/mL$serum)	Hypothyroid( $>40µU/mL$ serum)
------	-----------------------------------	----------------------------------------	------------------------------------

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Of the known positive samples (n=26) one sample (#20082070164) was classified as borderline by both the GSP and predicate assays. This sample was initially a borderline sample but a repeat sample tested was classified as hypothyroid as can be seen below.

Classification of diagnosed positive samples

Classification ofdiagnosed positivesamples	Normal(<20μU/mLserum)	Borderline(20-40 μU/mLserum)	Hypothyroid(>40μU/mL serum)
GSP	0	1*	25
Predicate	0	1*	25

Sample initial result was borderline (27 µU/mL serum)

The table below shows how the GSP and predicate assays have classified the same samples. It can be seen from the table some samples are exchanged between the borderline and normal classifications.

hTSH	Predicate
GSP	Normal	Borderline	Hypothyroid	Total
Normal	2000	22	1	2023
Borderline	11	45	0	56
Hypothyroid	0	0	25	25
Total	2011	67	26	2104

Distribution of samples into test results categories: GSP vs Predicate

The overall percent agreement, the positive agreement and the negative agreement are calculated along with 95% confidence intervals (95% CI). Results are presented in the table below and they show good agreement between methods.

The overall percent agreement, positive agreement and negative agreement

	Numerator	Denominator	PercentAgreement	95%CI
Overall percentagreement	2000+45+25	2104	98.4%	97.8%-98.9%
Positiveagreement	45+25	67+26	75.3%	66.0%-84.6%
Negativeagreement	2000	2011	99.5%	99.1%-99.8%

Internal Method Comparison

The 3301-001U GSP Neonatal hTSH kit was compared with the B032-312 AutoDELFIA Neonatal hTSH kit using routine screening and spiked blood spot samples, single measurements, in the range of 1.38 - 250 uUmL blood in the 3301-001U kit. The correlation from a weighted Deming regression was found to be;

95% CI slope (0.94, 1.01), intercept (-0.37, -0.16) N=162 Y = 0.97x - 0.21

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Image /page/7/Picture/0 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

PerkinElmer, Inc. c/o Ms. Kay A. Taylor Senior Manager, Regulatory Affairs 8275 Carloway Road Indianapolis, IN 46236

SEP - 3 2009

K090846 Re:

Trade/Device Name: GSP Neonatal hTSH kit Regulation Number: 21 CFR § 862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: Class II Product Code: JLW, KHO Dated: August 14, 2009 Received: August 18, 2009

Dear Ms. Taylor:

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 801), 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 premarket notification" (21 CFR Part 807.97). For questions 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.

G.C.H.

Courtney C. Harper, Ph.D. Acting 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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Indication for Use

510(k) Number (if known): K090846

Device Name: GSP Neonatal hTSH kit

Indication For Use:

Prescription Use XXX (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Dixision Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K090846

Page 1 of 2

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Indications for Use Form

510(k) Number (if known): K090846

Device Name: GSP Instrument

Indications for Use:

The GSPTM Instrument is a fully automated, high throughput batch analyzer for time resolved analysis of samples in microtitration plates. It is in intended for in vitro quantitative / qualitative determination of analytes in body fluids.

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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K090846

Page 2 of 2

Regulation Number and Section

§ 862.1690 Thyroid stimulating hormone test system.

(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.