ACE T4 REAGENT T4 CALIBRATORS

K981377 · Schiapparelli Biosystems, Inc. · KLI · Jun 10, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981377
• Device Name: ACE T4 REAGENT T4 CALIBRATORS
• Applicant: Schiapparelli Biosystems, Inc.
• Product Code: KLI · Clinical Chemistry
• Decision Date: Jun 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1700
• Device Class: Class 2

Intended Use

ACE® T4 Reagent is intended for use in the quantitative determination of thyroxine in human serum.

Device Story

ACE® T4 Reagent is an enzyme immunoassay for quantitative thyroxine (T4) measurement in human serum. It utilizes 8-anilino-1-naphthalene sulfonic acid (ANS) to dissociate T4 from plasma-binding proteins. Dissociated T4 competes with G6PDH-labeled T4 for anti-T4 antibody binding sites; enzyme activity is inhibited when T4-labeled G6PDH binds to the antibody. The device is used on the ACE clinical chemistry analyzer; enzyme activity is measured bichromatically at 340/505 nm by monitoring NAD+ to NADH conversion. The resulting enzyme activity is inversely proportional to T4 concentration. Results assist clinicians in diagnosing and managing thyroid disorders.

Clinical Evidence

Bench testing only. Performance assessment included within-run (3.7% CV) and between-run (4.6% CV) precision. Method correlation against a commercial thyroxine assay (Hitachi 717) yielded a slope of 1.070, intercept of -0.405, and r=0.9824 (N=50). Assay range is 0.47 µg/dL to 20 µg/dL.

Technological Characteristics

Liquid-based enzyme immunoassay reagents (Antibody/Substrate and Enzyme Conjugate). Detection via spectrophotometric bichromatic measurement (340/505 nm). Designed for use on the ACE clinical chemistry analyzer. Operates at 37 °C.

Indications for Use

Indicated for the quantitative determination of thyroxine in human serum for the diagnosis and treatment of thyroid disorders. For prescription use only.

Regulatory Classification

Identification

A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Diagnostic Reagents, Inc. (DRI) - Thyroxine (T4) Reagent (K944703)

Submission Summary (Full Text)

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# 510(k) PREMARKET NOTIFICATION ACE® T4 Reagent

K 981377

### 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® T4 Reagent |
|----------------------|-------------------------------------------------------------------------------------|
| Common Name: | Enzyme immunoassay for thyroxine |
| Classification Name: | Thyroxine test |
| Predicate Device: | Diagnostic Reagents, Inc. (DRI) - Thyroxine (T4) Reagent<br>[510(k) Number K944703] |

### Device Description

The ACE® T4 Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme The assay uses 8-anilino-1-naphthalene sulfonic acid (ANS) to dissociate Coniugate reagent. thyroxine from the plasma-binding proteins. The dissociated thyroxine in the sample competes with an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled thyroxine for a fixed amount of anti-thyroxine specific antibody binding sites. In the absence of thyroxine from the sample, the thyroxine-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between thyroxine concentration in the sample and the enzyme activity. The enzyme G6PDH 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® T4 Reagent is intended for use in the quantitative determination of thyroxine in human serum.

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# 510(k) PREMARKET NOTIFICATION ACE® T4 Reagent

# SUMMARY OF SAFETY AND EFFECTIVENESS

## COMPARATIVE FEATURES OF PREDICATE AND PROPOSED DEVICES

| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE |
|----------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------|
| Trade Name | DRI Thyroxine (T4) Enzyme<br>Immunoassay | ACE® T4 Reagent |
| Reference No. | K944703 | TBD |
| Analyte | Thyroxine | Thyroxine |
| Intended Use | Quantitative determination of<br>thyroxine | Quantitative determination of<br>thyroxine |
| Methodology | Enzyme immunoassay | Enzyme immunoassay |
| Reagents<br>Reagent 1<br>Volume | Liquid; Antibody/Substrate<br>210 µL | Liquid; Antibody/Substrate<br>210 µL |
| Reagent 2<br>Volume | Liquid; Enzyme conjugate<br>70 µL | Liquid; Enzyme conjugate<br>70 µL |
| Specimen<br>Type<br>Volume | Serum and plasma<br>5 µL | Serum<br>5 µL |
| Assay System<br>Reagent 1 + Sample<br>Reagent 2<br>Temperature | Incubate 288 sec<br>Read 72 to 132 sec (12 sec intervals)<br>37 °C | Incubate 240 sec<br>Read 63 and 203 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® T4 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<br>Precision<br>Within Run<br>Between Run | 0.7 µg/dL to 20 µg/dL<br>5.4 %CV<br>4.3 %CV | 0.47 µg/dL to 20 µg/dL<br>3.7 %CV<br>4.6 %CV |
| Correlation vs<br>Slope<br>Intercept<br>r<br>N | Commercial thyroxine assay<br>1.02<br>-0.63<br>0.993<br>108 | Hitachi 717<br>1.070<br>-0.405<br>0.9824<br>50 |

Based on these data, the Schiapparelli Biosystems ACE® T4 Reagent is substantially equivalent to the predicate device (Diagnostic Reagents, Inc. Thyroxine (T4) 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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JUN 1 0 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K981377 ACE® T4 Reagent II Requlatory Class: Product Code: KLI, JIS April 15, 1998 Dated: 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 Requlations, Title 21, Parts 800 to 895. ਕੇ 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 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 leqally 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 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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| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|-------------------------|
| 510(k) Number (if known): | K981377 |
| Device Name: | ACE" T4 Reagent |

Indications For Use:

..

ACE" T4 Reagent is used in the diagnosis and treatment of thyroid disorders. It is intended for the quantitative determination of thyroxine in serum using the ACE clinical chemistry analyzer.

| (Division Sign-Off) |
|---------------------|
|---------------------|

Division of Clinical Laboratory Devices

| 510(k) Number | k981377 |
|---------------|---------|
|---------------|---------|

(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)