ACE T UPTAKE REAGENT TU CALIBRATORS

K981375 · Schiapparelli Biosystems, Inc. · KHQ · Jun 10, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981375
• Device Name: ACE T UPTAKE REAGENT TU CALIBRATORS
• Applicant: Schiapparelli Biosystems, Inc.
• Product Code: KHQ · Clinical Chemistry
• Decision Date: Jun 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1715
• Device Class: Class 2

Intended Use

ACE® T Uptake Reagent is intended for use in the quantitative determination of unsaturated binding sites on the thyroid-binding proteins in human serum.

Device Story

ACE® T Uptake Reagent is an enzyme immunoassay for measuring unsaturated thyroxine-binding sites in human serum. The assay utilizes a mixture of G6PD-conjugated thyroxine (G6PD-T4) and exogenous T4. In the presence of serum, exogenous T4 binds to available thyroxine-binding proteins; remaining unbound G6PD-T4 is subsequently bound by an anti-T4 antibody, which inhibits enzyme activity. Conversely, samples with fewer unsaturated binding sites leave more exogenous T4 unbound, which inhibits the antibody-conjugate binding, resulting in higher G6PD enzyme activity. The device is used on the ACE clinical chemistry analyzer in a clinical laboratory setting. The analyzer measures G6PD activity bichromatically at 340/505 nm by monitoring the conversion of NAD+ to NADH. The resulting enzyme activity is inversely proportional to the concentration of unsaturated thyroxine-binding sites. Healthcare providers use these quantitative results to assess thyroid function and guide clinical decision-making for patients with suspected thyroid disorders.

Clinical Evidence

Bench testing only. Performance assessment included within-run and between-run precision and method correlation. Within-run precision was 3.7% CV and between-run was 4.1% CV (N=50). Method correlation against a Hitachi 717 assay showed a slope of 1.085, intercept of -3.460, and r=0.935.

Technological Characteristics

Enzyme immunoassay; liquid reagents (enzyme conjugate and antibody/substrate); spectrophotometric detection; bichromatic measurement at 340/505 nm; assay temperature 37°C; intended for use on the ACE clinical chemistry analyzer.

Indications for Use

Indicated for the quantitative determination of unsaturated binding sites on thyroid-binding proteins in human serum to aid in the diagnosis and treatment of thyroid disorders.

Regulatory Classification

Identification

A triiodothyronine uptake test system is a device intended to measure the total amount of binding sites available for binding thyroid hormone on the thyroxine-binding proteins, thyroid-binding globulin, thyroxine-binding prealbumin, and albumin of serum and plasma. The device provides an indirect measurement of thyrkoxine levels in serum and plasma. Measurements of triiodothyronine uptake are used in the diagnosis and treatment of thyroid disorders.

Predicate Devices

• Diagnostic Reagents, Inc. (DRI) - T Uptake Reagent (K951586)

Submission Summary (Full Text)

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### JUN 1 0 1998

### 510(k) PREMARKET NOTIFICATION ACE® T Uptake Reagent

K981375

### SUMMARY OF SAFETY AND EFFECTIVENESS

In lieu of a 510(k) statement under 513(i) of the Act, this Summary of Safety and Effectiveness is provided as a 510(k) summary for disclosure to any other persons/companies without specific written authorization from Schiapparelli Biosystems, Inc.

#### Submitter

Schiapparelli Biosystems. Inc. 368 Passaic Avenue Fairfield, NJ 07004 Phone: [phone]

#### Contact Person

Steven Dalessio Manager, Quality Assurance/Regulatory Affairs Phone: [phone]

#### Device Names

| Proprietary Name: | ACE® T Uptake Reagent |
|----------------------|-------------------------------------------------------------------------------|
| Common Name: | Enzyme immunoassay for T Uptake |
| Classification Name: | T Uptake test |
| Predicate Device: | Diagnostic Reagents, Inc. (DRI) - T Uptake Reagent<br>[510(k) Number K951586] |

#### Device Description

The ACE T Uptake Regent contains two reagents, and Antibody/Substrate reagent and an Enzyme The assay uses a mixture of enzyme glucose-6-phosphate dehydrogenase Conjugate reagent. conjugated thyroxine (G6PD-T4) and a known amount of exogeneous T4 which is allowed to bind to the thyroxine-binding proteins in the sample. A sample with increased levels of unsaturated thyroxine-binding sites, the exogeneous T4 will bind leaving G6PD-T4 conjugate free. On addition of an anti-thyroxine antibody, the G6PD-T4 conjugate is bound by the antibody and the enzyme activity is inhibited. Conversely, a sample with decreased levels of unsaturated thyroxine-binding sites will leave most exogeneous T4 unbound. Upon addition of anti-T4 antibody, the unbound exogeneous T4 will inhibit the anti-T4 binding to G6PD-T4 conjugate and produce a high G6PD enzyme activity. This phenomenon creates a relationship between unsaturated thyroxine-binding sites concentration (T Uptake) and the enzyme activity. The enzyme G6PD activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD* to NADH.

#### Intended Use of the Device

ACE® T Uptake Reagent is intended for use in the quantitative determination of unsaturated binding sites on the thyroid-binding proteins in human serum.

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## 510(k) PREMARKET NOTIFICATION ACE® T Uptake Reagent

## SUMMARY OF SAFETY AND EFFECTIVENESS

# COMPARATIVE FEATURES OF PREDICATE AND PROPOSED DEVICES

| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Trade Name | DRI T Uptake Enzyme Immunoassay | ACE® T Uptake Reagent |
| Reference No. | K951586 | TBD |
| Analyte | T Uptake | T Uptake |
| Intended Use | Quantitative determination of<br>unsaturated binding sites on the<br>thyroid-binding proteins | Quantitative determination of<br>unsaturated binding sites on<br>the thyroid-binding proteins |
| Methodology | Enzyme immunoassay | Enzyme immunoassay |
| Reagents<br>Reagent 1<br>Volume | Liquid; Enzyme conjugate<br>210 µL | Liquid; Enzyme conjugate<br>210 µL |
| Reagent 2<br>Volume | Liquid; Antibody/Substrate<br>70 µL | Liquid; Antibody/Substrate<br>70 µL |
| Specimen<br>Type<br>Volume | Serum and plasma<br>9 µL | Serum<br>9 µL |
| Assay System<br>Reagent 1 + Sample<br>Reagent 2<br>Temperature | Incubate 288 sec<br>Read 120 to 192 sec (12 sec intervals)<br>37 °C | Incubate 240 sec<br>Read 63 and 273 sec<br>37 °C |
| Detection Method<br>Type<br>Wavelength, nm | Spectrophotometric<br>Bichromatic: 340/415 | Spectrophotometric<br>Bichromatic: 340/505 |

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## 510(k) PREMARKET NOTIFICATION ACE® T Uptake Reagent

## SUMMARY OF SAFETY AND EFFECTIVENESS

### PERFORMANCE ASSESSMENT

Non-clinical test results submitted in the premarket notification include within-run and between-run precision and method correlation. Following is a data summary.

| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE |
|------------------------------------|------------------------------|--------------------------------|
| Performance Summary<br>Assay Range | 15% to 50% | 15% to 50% |
| Precision<br>Within Run | 3.6 %CV | 3.7 %CV |
| Between Run | 3.3 %CV | 4.1 %CV |
| Correlation vs | Commercial EIA assay for FTI | Hitachi 717 Assay for T Uptake |
| Slope | 0.92 | 1.085 |
| Intercept | 0.69 | -3.460 |
| r | 0.9 | 0.935 |
| N | 110 | 50 |

Based on these data, the Schiapparelli Biosystems ACE® T Uptake Reagent is substantially equivalent to the predicate device (Diagnostic Reagents, Inc. T Uptake Enzyme Immunoassay). On this basis, the reagent is determined to be safe and effective for its intended use. Performance details are included in the reagent product labeling.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circle. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 1 0 1998

Steven Dalessio . Manager, Quality Assurance/Regulatory Affairs Schiapparelli Biosystems, Inc. 368 Passaic Avenue Fairfield, New Jersey 07004

Re : K981375 ACE® T Uptake Reagent Requlatory Class: II Product Code: KHQ, JIS Dated: April 15, 1998 Received: April 16, 1998

Dear Mr. Dalessio:

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 Regulations, Title 21, Parts 800 to 895. A 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 Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 regulations.

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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

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1375 510(k) Number (if Known):

ACE T Uptake Reagent Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

ACE T Uptake Reagent is used in the diagnosis and treatment of thyroid disorders. It is intended for the quantitative determination of unsaturated binding sites on the thyroid-binding proteins in serum using the ACE clinical chemistry analyzer.

510(k) Number: k 981375

(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_

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(Optional Format 1-2-96)