UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)

K974721 · Bayer Corp. · CGI · Mar 3, 1998 · Clinical Chemistry

Device Facts

• Record ID: K974721
• Device Name: UNCONJUGATED ESTRIOL ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
• Applicant: Bayer Corp.
• Product Code: CGI · Clinical Chemistry
• Decision Date: Mar 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1265
• Device Class: Class 1

Intended Use

This in vitro diagnostic method is intended to quantitatively measure unconjugated estriol (uE3) in human serum on the Bayer Immuno 1™ system. Measurements of uE3 are used in evaluating fetal well-being by monitoring the level of the hormone derived from fetal-placental circulation. This diagnostic method is not intended for use on any other system.

Device Story

The Bayer Immuno 1 System Unconjugated Estriol (uE3) assay is an in vitro diagnostic method for the quantitative measurement of uE3 in human serum. The device operates on the Bayer Immuno 1 System, an automated clinical laboratory analyzer. It measures hormone levels to assist clinicians in evaluating fetal well-being. The system processes serum samples to determine uE3 concentrations, which are then reported to healthcare providers to inform clinical decision-making regarding fetal-placental health. The device is intended for professional use in clinical laboratory settings.

Clinical Evidence

Bench testing only. Performance evaluated via precision studies (n=20 over 10 days) and method comparison against the predicate (n=249). Precision results showed within-run CVs ranging from 1.5% to 3.6% and total CVs from 2.3% to 4.9%. Correlation with predicate yielded r=0.98.

Technological Characteristics

In vitro diagnostic immunoassay reagents and calibrators for use on the automated Bayer Immuno 1 System. Measures unconjugated estriol via immunoassay principle. Performance characteristics include specific cross-reactivity profiles for various estrogenic compounds and metabolites.

Indications for Use

Indicated for the quantitative measurement of unconjugated estriol in human serum to evaluate fetal well-being by monitoring hormone levels derived from fetal-placental circulation.

Regulatory Classification

Identification

An estriol test system is a device intended to measure estriol, an estrogenic steroid, in plasma, serum, and urine of pregnant females. Estriol measurements are used in the diagnosis and treatment of fetoplacental distress in certain cases of high-risk pregnancy.

Predicate Devices

• Diagnostic Products Corporation Coat-a-Count Free Estriol RIA method

Submission Summary (Full Text)

{0}------------------------------------------------

## Attachment 3

# Summary of Safety and Effectiveness

1114121

MA

ുവള

## Unconjugated Estriol Method for the Bayer Immuno 1" System

Listed below is a comparison of the performance of the Bayer Immuno 1™ Unconjugated Estriol method and a similar device granted clearance of substantial equivalence (Diagnostic Products Corporation Coat-a-Count Free Estriol RIA method). The information below was extracted from the Bayer Immuno 1 Unconjugated Estriol method sheet and the DPC Free Estriol RIA Package Insert.

## Intended Use

This in vitro diagnostic method is intended to quantitatively measure unconjugated estriol in human serum on the Bayer Immuno 1 System. Measurements of unconjugated estriol are used to evaluate fetal well-being by monitoring the level of the hormone derived from fetal-placental circulation.

| uEstriol Method: | Bayer Immuno 1™ | | DPC Coat-a-Count® | | |
|-------------------------|------------------------------|-------------|-----------------------------------|----------------------------|--|
| Part Number: | Reagents | T01-3987-51 | kit(s) | TKEF1 (100)<br>TKEF5 (500) | |
| | Calibrators | T03-3986-01 | | | |
| Expected Values: | <2.0 to 42.0 ng/mL | | graphical | | |
| Precision (within-run): | mean | % CV | mean | % CV | |
| (n = 20 over 10 days) | 0.41 | 3.6% | 0.74 | 9.1 | |
| | 3.60 | 3.2% | 2.9 | 5.5 | |
| | 6.49 | 1.5% | 7.9 | 3.8 | |
| | 11.37 | 2.3% | 12.2 | 3.8 | |
| Precision (total): | (inter-assay only presented) | | | | |
| (n = 20 over 10 days) | 0.41 | 4.9% | 0.74 | 21.2 | |
| | 3.60 | 3.4% | 2.90 | 9.3 | |
| | 6.49 | 2.3% | 7.90 | 9.9 | |
| | 11.37 | 2.7% | 12.20 | 8.0 | |
| Regression Equation: | y = 0.87x + 0.62 | | | | |
| where: | y | = | Immuno 1 uE3 Assay | | |
| | x | = | DPC Coat-a-Count Free Estriol RIA | | |
| | n | = | 249 | | |
| | r | = | 0.98 | | |
| | Sy.x | = | 1.23 | | |
| | range | = | 0 to 30 ng/ml | | |

{1}------------------------------------------------

## Specificity: Cross Reactants Spiked into Normal Human Serum Pools

| Compound | DPC Free Estriol<br>% Crossreactivity | Bayer Immuno 1 uE3<br>% Crossreactivity |
|--------------------------------|---------------------------------------|-----------------------------------------|
| Estriol-3-sulfate | 0.46% | 1.70% |
| Estriol-3-(β-D-glucuronide) | 0.26% | 1.60% |
| Estriol-16-α-(β-D-glucuronide) | 0.66% | 0.05% |
| Estriol-17-β-(β-D-glucuronide) | not detected | 0.08% |
| Estradiol | 0.13% | 0.44% |
| Estrone | 0.05% | 0.06% |
| Estrone-β-D-glucuronide | not detected | 0.07% |
| Estrone-3-sulfate | not detected | 0.06% |
| 16-Epiestriol | 0.26% | 0.30% |
| 17-Epiestriol | 0.10% | 1.00% |
| Cortisol | not detected | not detected |
| 11-deoxycortisol | not detected | not detected |
| 5α-Dihydroxytestosterone | not detected | not detected |
| Testosterone | 0.003% | not detected |
| 16a-Hydroxyestrone | not reported | 7.60% |

Gabriel J. Munaco Jr.

Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

12/11/97

---

Date

Image /page/1/Picture/5 description: The image shows a black and white drawing of a golf ball. The golf ball is round and has a textured surface with many small dimples. The lighting in the image creates a shadow on the right side of the golf ball, giving it a three-dimensional appearance.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Gabriel Muraca, Jr. Manager Requlatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

MAR - 3 1998

K974721 Re : Unconjugated Estriol Assay for the Bayer Immuno 1™ System Requlatory Class: I Product Code: CGI Dated: December 18, 1997 Received: December 18, 1997

Dear Mr. Muraca:

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 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 (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. ਬ 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 requlations.

{3}------------------------------------------------

Page 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 regulation (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 Gutman

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

{4}------------------------------------------------

Attachment 7

Page 1 of 1

974721

510(k) Number (if known):

Device Name: Bayer Immuno 1TM System Unconjugated Estriol

Indications For Use:

This in vitro diagnostic method is intended to quantitatively measure unconjugated estriol (uE¿) in human serum on the Bayer Immuno 1™ system. Measurements of uE, are used in evaluating fetal well-being by monitoring the level of the hormone derived from fetal-placental circulation.

This diagnostic method is not intended for use on any other system.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. k974721

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

Optional Format 1-2-96)