GSP INSTRUMENT AND GSP NEONATAL HTSH KIT

K090846 · Perkinelmer, Inc. · JLW · Sep 3, 2009 · Clinical Chemistry

Device Facts

• Record ID: K090846
• Device Name: GSP INSTRUMENT AND GSP NEONATAL HTSH KIT
• Applicant: Perkinelmer, Inc.
• Product Code: JLW · Clinical Chemistry
• Decision Date: Sep 3, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1690
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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™ Neonatal hTSH 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.

Device Story

GSP instrument is a fully automated, high-throughput batch analyzer for time-resolved fluoroimmunoassay; processes dried blood spot (DBS) samples on microtitration plates. System uses two monoclonal antibodies in a sandwich immunoassay to detect hTSH; europium-labeled tracer and DELFIA Inducer generate fluorescent signal proportional to hTSH concentration. Operated by laboratory personnel in clinical settings. GSP software (Windows Vista embedded) manages worklists, plate identification via barcode, and data processing. Results are used by clinicians alongside other clinical data to screen for congenital hypothyroidism. Benefits include high-throughput, automated processing of neonatal screening samples, reducing manual labor and improving consistency in hTSH quantification.

Clinical Evidence

Clinical performance evaluated via comparison studies at two sites (n=2053 and n=2104 samples). Overall percent agreement with predicate was 98.4% at both sites. Positive agreement ranged 75.3%–75.9%; negative agreement 99.4%–99.5%. Analytical performance included precision (total CV 7.7%–10.1%), linearity (0.66–375 µU/mL), and LoQ (1.31 µU/mL). No interference observed from bilirubin, lipids, or hemoglobin.

Technological Characteristics

Solid-phase, two-site fluoroimmunometric assay. Materials: Whatman 903 filter paper, mouse monoclonal antibodies, europium-labeled tracer. Energy: Time-resolved fluorescence. Connectivity: Barcode reader, GSP Workstation interface. Software: Windows Vista embedded. Sterilization: Not applicable (reagents). Dimensions: High-throughput batch analyzer with 24-plate capacity.

Indications for Use

Indicated for newborns to screen for congenital (neonatal) hypothyroidism via quantitative determination of hTSH in dried blood spot specimens.

Regulatory Classification

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.

Predicate Devices

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

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 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: [phone]

Raija Koskivaara Tele: (011) [phone] Fax: (011) [phone]

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 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

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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<br>(K935047) |
| Intended<br>Use/Indications for<br>Use | The GSPT™ instrument is a fully<br>automated, high throughput batch<br>analyzer for time resolved<br>analysis of samples in<br>microtitration plates. It is<br>intended for <i>in vitro</i> quantitative /<br>qualitative determination of<br>analytes in body fluids. The GSP<br>instrument and GSP chemistries<br>are for professional use only. | The Wallac 1235 AutoDELFIA<br>automatic immunoassay system is<br>designed to automatically perform<br>assays using the DELFIA<br>technology. DELFIA is based on<br>the proven and widely used method<br>of time-resolved fluorometry. |
| Intended User | Same | Adequately trained laboratory<br>personnel performing newborn<br>screening |
| Test Mode | Same | Batch mode |
| Detection<br>Technology | 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 separate<br>barcode labels |
| User Interface | GSP software -MicroSoft<br>Windows Vista embedded - touch<br>screen | AutoDELFIA Workstation software<br>(MicroSoft Windows - resides on<br>external PC - keyboard, mouse |
| Instrument<br>Components | Instrument (consists of plate<br>manipulator and modules).<br>External PC<br>Barcode reader. | Sample processor<br>Plate processor<br>External 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 a<br>hematocrit value of 50-55% |
| | Filter paper cassettes (Whatman | Filter paper sheets |
| Matrix | no.903) | (Whatman no. 903) |
| Concentrations | Same | A 1 µU/mL blood<br>B 10 µU/mL blood<br>C 25 µU/mL blood<br>D 50 µU/mL blood<br>E 100 µU/mL blood<br>F 250 µU/mL blood |
| Controls | Same | Two levels of hTSH controls |
| Source | Same | Human whole blood with a<br>hematocrit value of 50-55% |
| Matrix | Filter paper cassettes (Whatman<br>no.903) | Filter paper sheets<br>(Whatman no. 903) |
| Concentrations | Same | Approx. values:<br>C1 15 µU/mL blood<br>C2 60 µU/mL blood |
| Tracer | Anti-h-TSH-Eu solution (~5<br>µg/mL); 3vials, 2.8 mL | Anti-h-TSH-Eu stock solution (~20<br>µg/mL); 6vials, 1.1 mL |
| | The tracer is Eu-N3-labeled<br>antibody (clone 5409) | The tracer is Eu-N1-labeled<br>antibody (clone 5403) |
| Assay Buffer | Same | Neo hTSH Assay Buffer<br>3 bottles, 120 mL |
| Plates | Anti-hTSH Microtitration Strips<br>(Nunc); 12 plates | Anti-hTSH Microtitration Strips<br>(Thermo Electron); 12 plates |
| Detection | Same | Defined by analyte specific protocol |
| | X-axis LIN, Y-axis LIN; fitting<br>algorithm 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 mean<br>value µU/mL<br>blood | Within-run<br>variation<br>(% CV) | Within-lot<br>variation<br>(% CV) | Total<br>variation<br>(% 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 mean<br>value µU/mL<br>blood | Within-run<br>variation<br>(% CV) | Within-lot<br>variation<br>(% CV) | Total<br>variation<br>(% 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 | Added<br>concentration | Measured apparent<br>TSH concentration<br>(\u03BCU/mL blood) | Measured TSH<br>concentration without<br>interferent<br>(\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<br>(<20µU/mL<br>serum) | Borderline<br>(20-40 µU/mL<br>serum) | Hypothyroid<br>(>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 of<br>diagnosed positive<br>samples | Normal<br>(<20µU/mL<br>serum) | Hypothyroid<br>(>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 | Total |
|-------------|------|--------|------------|-------------|-------|
| 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 | Percent<br>Agreement* | 95%CI* | |
|------------------------------|-------------|-----------------------|--------|-------------|
| Overall percent<br>agreement | 1958+41+22 | 2053 | 98.4% | 97.9%-99.0% |
| Positive<br>agreement | 41+22 | 61+22 | 75.9% | 66.1%-85.7% |
| Negative<br>agreement | 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<br>( $ <20µU/mL$<br>serum) | Borderline<br>(20-40 $µU/mL$<br>serum) | Hypothyroid<br>( $>40µU/mL$ 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 of<br>diagnosed positive<br>samples | Normal<br>(<20μU/mL<br>serum) | Borderline<br>(20-40 μU/mL<br>serum) | Hypothyroid<br>(>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 | Percent<br>Agreement | 95%CI |
|------------------------------|------------|-------------|----------------------|-------------|
| Overall percent<br>agreement | 2000+45+25 | 2104 | 98.4% | 97.8%-98.9% |
| Positive<br>agreement | 45+25 | 67+26 | 75.3% | 66.0%-84.6% |
| Negative<br>agreement | 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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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 [phone]. 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 [phone]. 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 [phone] 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:

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.

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

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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

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