AUTODELFIA NEONATAL HTSH L KIT (B077-112)

K973276 · Eg &G Wallac · JLW · Nov 20, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973276
• Device Name: AUTODELFIA NEONATAL HTSH L KIT (B077-112)
• Applicant: Eg &G Wallac
• Product Code: JLW · Clinical Chemistry
• Decision Date: Nov 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1690
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The kit is intended for the quantitative determination of thyrotropin in blood specimens dried on filter paper as an aid in screening newborns for congenital (neonatal) hypothyroidism, using the 1235 AutoDELFIA™ automatic immunoassay system.

Device Story

AutoDELFIA™ Neonatal hTSH L Kit is an in vitro diagnostic assay for neonatal hypothyroidism screening. Input: dried blood spot specimens on filter paper. Principle: solid-phase, two-site fluoroimmunometric sandwich assay using monoclonal antibodies against hTSH. Assay buffer elutes hTSH from filter paper; simultaneous reaction with immobilized antibodies occurs in one incubation step. Enhancement solution dissociates europium ions from labeled antibodies to form fluorescent chelates. Output: fluorescence measurement proportional to hTSH concentration, processed by 1235 AutoDELFIA™ automatic immunoassay system. Used in clinical laboratory settings by trained personnel. Results assist clinicians in identifying newborns requiring further diagnostic evaluation for congenital hypothyroidism.

Clinical Evidence

Clinical comparison performed on 860 newborn samples using both the subject device and the predicate device. Reference range for the subject device was 0.69 - 12.7 µU/mL blood (mean 4.13 µU/mL) compared to 0.55 - 14.9 µU/mL (mean 3.96 µU/mL) for the predicate. Frequency distribution data provided to demonstrate equivalence.

Technological Characteristics

Solid-phase, two-site fluoroimmunometric sandwich assay. Utilizes monoclonal antibodies and europium-labeled antibodies. Detection via time-resolved fluorescence. Requires 1235 AutoDELFIA™ automatic immunoassay system for processing and measurement. Standards and controls utilize a liquid matrix.

Indications for Use

Indicated for quantitative determination of thyrotropin in dried blood spot specimens from newborns as an aid in screening for congenital hypothyroidism.

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™ Neonatal hTSH kit (K933267)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for EG&G, a former American science and technology company. The logo consists of a stylized symbol on the left, resembling a three-pronged fork or a stylized letter. To the right of the symbol are the letters "EG&G" in a bold, sans-serif font. The letters are closely spaced and appear to be in black, contrasting with the white background.

NOV 20 199

238 GAITHER RD. GAITHERSBURG, MD 20877 U.S.A. ELEPHONE: [phone] 1-800-638-6692 FAX: [phone]

#### 510(k) Summary Re:

August 26, 1997 Date:

- Submitter: EG&G Wallac Inc. 9238 Gaither Road Gaithersburg, MD 20877
Telephone: [phone]

[phone] Fax:

Paul D. Davis Contact:

AutoDELFIA™ Neonatal hTSH L Kit Trade Name:

Neonatal hTSH Liquid Time-Resolved Fluoroimmunoassay Common Name:

Thyroid Stimulating Hormone Test System Classification Name:

AutoDELFIATM Neonatal hTSH Kit Predicate Device:

Device Description:

The AutoDELFIA™ Neonatal hTSH L assay is a solid phase, two-site fluoroimmunometric assay based on the direct sandwich technique in which two monoclonal antibodies are directed against separate antigenic determinants on the hTSH molecule. Standards, controls and test specimen containing hTSH are reacted simultaneously with immobilised monoclonal antibodies in assay buffer. The assay buffer elutes hTSH from the dried blood spots on the filter paper discs. The complete assay requires only one incubation step. Enhancement solution dissociates europium ions from the labelled antibody into solution where they form highly fluorescent chelates with components of the enhancement solution. The fluorescence in each well is then measured. The fluorescence of each sample is proportional to the concentration of hTSH in the sample.

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# 510(k) Summary Cont'd

### Intended Use:

The kit is intended for the quantitative determination of thyrotropin in blood specimens dried on filter paper as an aid in screening newborns for congenital hypothyroidism, using the 1235 AutoDELFIA™ automatic immunoassay system

### Equivalence Comparison:

The AutoDELFIA™ Neonatal hTSH L kit was compared to the AutoDELFIA™ Neonatal hTSH kit and found to be substantially equivalent. The major difference between the kits is the matrix of the standards and controls. The predicate device utilizes a paper matrix while the new device utilizes a liquid matrix. In addition, a medium control has been added.

hTSH concentrations were measured in 860 newborns with the AutoDELFIA™ Neonatal hTSH kit and with the AutoDELFIA™ Neonatal hTSH L kit. The reference range when measured with the AutoDELFIA™ Neonatal hTSH kit was 0.55 - 14.9 µU/mL blood, with a mean value of 3.96 µU/mL blood. The reference range when measured with the AutoDELFIA™ Neonatal hTSH L kit was 0.69 - 12.7 µU/mL blood, with a mean value of 4.13 uU/mL blood. The frequency distributions are shown in the following figure:

Image /page/1/Figure/6 description: This bar graph compares AutoDELFIA Neonatal hTSH and AutoDELFIA Neonatal hTSH L. The x-axis shows ranges from 0-2 to >20, while the y-axis shows values from 0 to 400. For the range 0-2, AutoDELFIA Neonatal hTSH is at approximately 170, while AutoDELFIA Neonatal hTSH L is at approximately 120.

hTSH µU/mL blood (hTSH µU/mL serum)

9-2

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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

NOV 20 19

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Paul D. Davis .Manager of Quality and Regulatory Affairs EG&G Wallac Inc. 9238 Gaither Road Gaithersburg, Maryland 20877

Re : K973276 AutoDELFIA™ Neonatal hTSH L Kit Requlatory Class: II Product Code: JLW Dated: November 4, 1997 Received: November 7, 1997

Dear Mr. Davis:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval); it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Paqe 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

sincerely yours,
Steven Bitman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 2. Device Name [807.87(a)]

- A. Trade Name:
AutoDELFIA™ Neonatal hTSH L Kit

# B. Common Name:

Neonatal hTSH Liquid Time-Resolved Fluoroimmunoassay

# C. Classification Name:

Thyroid Stimulating Hormone Test System

# D. Indications for use:

This kit is intended for the quantitative determination of thyrotropin in blood specimens dried on filter paper as an aid in screening newborns for congenital (neonatal) hypothyroidism, using the 1235 AutoDELFIA™ automatic immunoassay system.

\Prescription Use

510(k), k933267