ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER

K973966 · Beckman Instruments, Inc. · CDP · Oct 31, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973966
• Device Name: ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
• Applicant: Beckman Instruments, Inc.
• Product Code: CDP · Clinical Chemistry
• Decision Date: Oct 31, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1710
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ACCESS® Total T3 Assay is a paramagnetic particle, chemiluminescent immunoassay for the guantitative determination of triiodothyronine levels in human serum, using the ACCESS® mmunoassay System. The clinical importance of total serum T3 determination is in the diagnosis of thyroid disorders. Elevated concentrations of T3 can be found in Grave's disease, and most other classical causes of hyperthyroidism. Decreased concentrations occur in primary hypothyroid diseases such as Hashimoto's thyroiditis and neonatal hypothyroidism or secondary hypothyroidism due to defects at the hypothalamo-hypophyseal level.

Device Story

ACCESS® Total T3 assay is a paramagnetic particle chemiluminescent immunoassay used with the ACCESS® Immunoassay Analyzer for quantitative measurement of triiodothyronine in human serum. The system utilizes competitive binding immunoassay technology; patient serum is incubated with a T3 analogue and an alkaline phosphatase-conjugated monoclonal anti-T3 antibody. The antibody binds to streptavidin-coated paramagnetic particles. A dioxetane-based chemiluminescent substrate is added; the resulting light emission is measured by a luminometer. The system is intended for clinical laboratory use. Output is a quantitative T3 concentration value, which assists clinicians in diagnosing thyroid disorders by identifying elevated or decreased T3 levels. The device provides automated analysis, replacing manual or less efficient methods, and supports clinical decision-making regarding thyroid function.

Clinical Evidence

Bench testing only. Precision studies showed within-run CV 3.22-5.22% and total imprecision 4.74-9.12%. Accuracy evaluated via dilution recovery (85.6-107.7%) and spiking recovery (87.7-112.1%). Correlation study with 153 samples against predicate device yielded r=0.978 and regression y=1.020x+0.077. Analytical sensitivity (lowest detectable level) is 0.1 ng/ml with 95% confidence.

Technological Characteristics

Paramagnetic particle-based competitive immunoassay. Uses streptavidin-coated paramagnetic particles, T3 analogue, and alkaline phosphatase-conjugated monoclonal anti-T3 antibody. Detection via luminometer measuring light from dioxetane-based chemiluminescent substrate. Six-point calibration. System is an automated immunoassay analyzer.

Indications for Use

Indicated for quantitative determination of triiodothyronine (T3) in human serum to aid in the diagnosis of thyroid disorders, including hyperthyroidism (e.g., Grave's disease) and hypothyroidism (e.g., Hashimoto's thyroiditis, neonatal hypothyroidism, secondary hypothyroidism).

Regulatory Classification

Identification

A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.

Predicate Devices

• Ciba Corning ACS™ T3

Submission Summary (Full Text)

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510(k) Premarket Notification Confidential

K973966

OCT 31 1997

### 1. General Information

Device Generic Name: Device Trade Name: Applicant's Name and Address:

Enzyme Immunoassav, Total T3 ACCESS® Total T3 assay Beckman Instruments, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318

#### 2. Predicate Device

Ciba Corning ACS™ T3 Ciba Corning Diagnostics Corp. Medfield, MA 02052

APPENDIX 4: Summary of Safety and Effectiveness Information

#### 3. Device Description

The ACCESS® Total T3 reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of triiodothyronine in human serum.

#### 4. Indications for Use

The ACCESS® Total T3 assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of trijodothyronine levels in human serum using the ACCESS® Immunoassav System.

#### 5. Comparison of Technological Characteristics

Both the ACCESS® Total T3 assay and the Ciba Corning ACS™ T3 assay measure triiodothyronine in human serum. The ACCESS® Total T3 assay and the Ciba Corning ACS™ T3 assay are competitive binding immunoassays. Both assays utilize microparticle technology. The ACCESS® Total T3 binds streptavidin to paramagnetic particles and Ciba Corning ACS™ T3 binds T3 analogue to paramagnetic particles. Both assays use light generated from a chemiluminescent reaction which is measured in a luminometer. Both assavs use a T3 analoque and an alkaline phosphatase coniugated monoclonal anti-T3 antibody. The ACCESS® Total T3 assay uses a monoclonal anti-T3 antibody conjugated to alkaline phosphatase which acts on a dioxetane based chemiluminescent substrate to produce light. The Ciba Corning ACS™ T3 assay uses a monoclonal anti-T3 antibody coniugated to acridinium ester which when activated by hydrogen peroxide and weak sodium peroxide produces light. The ACCESS® Total T3 assay uses a six point calibration while the Ciba Corning ACS™ T3 assay uses a two point calibration. The ACCESS® Total T3 assay utilizes a T3 analogue coupled to biotin while the Ciba Corning ACS™ utilizes a T3 analoque coupled to particles.

#### 6. Summary of Studies

Precision studies: Within run precision ranges from 3.22% CV (high control) to 5.22% CV (low control). Total imprecision ranges from 4.74% CV (high control) to 9.12% CV (low control). Accuracy: Dilution recovery studies performed by diluting two patient samples containing Total T3 with Total T3 Calibrator S0 range from 85.6% to 107.7% recovery. Spiking recovery studies performed by adding T3 to two patient samples containing low levels of T3 range from 87.7% to 112.1 % recovery.

Correlation: A comparison of Total T3 values from 153 samples run in both the ACCESS® Total T3 assay and the Ciba Corning ACS™ T3 assay gives the following statistical data using deming calculations: r = 0.978, v = 1.020x + 0.077.

Analytical Sensitivity: The lowest detectable level of total T3 distinguishable from zero (Total T3 Calibrator S0) with 95% confidence is 0.1 ng/ml.

#### 7. Conclusion

The ACCESS® Total T3 reagents when used with the ACCESS® Immunoassay Analyzer are substantially equivalent to another test for the measurement of Total T3 commercial distribution.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 31 1997

Shellie Gust Requlatory Specialist Beckman Instruments, Inc. 100 Lake Hazeltine Drive Chaska, Minnesota 55318-1084

K973966 Re: Enzyme Immunoassay, Total T3 ACCESS® Total T3 Assay Regulatory Class: II Product Code: CDP, JIS Dated: October 16, 1997 October 17, 1997 Received:

Dear Ms. Gust:

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 reqistration, listing of devices, qood 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. 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 Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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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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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# INDICATIONS FOR USE STATEMENT

10(k) Number ( if known): K973966

bevice Name: ACCESS® Total T3 Reagents on the ACCESS® Immunoassay Analyzer

ndications For Use:

The ACCESS® Total T3 Assay is a paramagnetic particle, chemiluminescent immunoassay for the guantitative determination of triiodothyronine levels in human serum, using the ACCESS® mmunoassay System.

The clinical importance of total serum T3 determination is in the diagnosis of thyroid disorders. Elevated concentrations of T3 can be found in Grave's disease, and most other classical causes of hyperthyroidism. Decreased concentrations occur in primary hypothyroid diseases such as Hashimoto's thyroiditis and neonatal hypothyroidism or secondary hypothyroidism due to defects at the hypothalamo-hypophyseal level.

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory
510(k) Number K973966


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