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.

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.

AI/ML Overview

Acceptance Criteria and Device Performance Study for ACE® T Uptake Reagent (K981375)

This document describes the acceptance criteria and a summary of the performance study for the ACE® T Uptake Reagent, based on the provided 510(k) premarket notification.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ACE® T Uptake Reagent are implicitly defined by its substantial equivalence to the predicate device (Diagnostic Reagents, Inc. T Uptake Enzyme Immunoassay, K951586). The study aimed to demonstrate that the new device's performance characteristics are comparable to, or better than, the predicate device.

Performance Characteristic	Acceptance Criteria (from Predicate Device)	Reported Device Performance (ACE® T Uptake Reagent)
Assay Range	15% to 50%	15% to 50%
Precision
Within Run (%CV)	3.6% CV	3.7% CV
Between Run (%CV)	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 (correlation coefficient)	0.9	0.935

Note: The document explicitly states that "Based on these data, the Schiapparelli Biosystems ACE® T Uptake Reagent is substantially equivalent to the predicate device." This implies that meeting or closely matching the predicate's performance metrics served as the acceptance criteria.

2. Sample Size and Data Provenance for the Test Set

Sample Size (for correlation study): N = 50
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, given that this is a 510(k) submission for a diagnostic reagent, it is highly probable that the data was generated prospectively during a validation study conducted in a clinical laboratory setting, likely within the United States.

3. Number and Qualifications of Experts for Ground Truth

Number of Experts: Not applicable. This type of device (reagent for quantitative determination) does not typically involve expert interpretation of results for establishing ground truth in the same way an imaging device might. The "ground truth" for the test set is established through comparison with a recognized reference method or predicate device.
Qualifications of Experts: Not applicable for this specific type of device and study design.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The "ground truth" is established by the results of the comparative methods (predicate device and Hitachi 717 Assay for T Uptake), not through expert adjudication. Discrepancies would be handled through technical investigation of the assay performance, not by an adjudication panel.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No. A multi-reader multi-case (MRMC) comparative effectiveness study is not relevant for this type of in vitro diagnostic (IVD) reagent. MRMC studies are typically performed for imaging or interpretation-based diagnostic devices where human readers are involved in the diagnostic process.

6. Standalone (Algorithm Only) Performance

Standalone Performance Study: Yes, in effect. The performance data presented (Assay Range, Precision, Correlation) directly reflects the standalone performance of the ACE® T Uptake Reagent as an algorithm/reagent system. There is no human-in-the-loop component in the fundamental operation of this quantitative assay. The device itself (ACE® T Uptake Reagent) is the "algorithm" and its performance is evaluated directly.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for the performance assessment was established through comparison with a legally marketed predicate device (Diagnostic Reagents, Inc. T Uptake Enzyme Immunoassay) and another commercial assay (Hitachi 717 Assay for T Uptake). Specifically, the correlation study used the results from these established methods as the reference for assessing the accuracy of the proposed device.

8. Sample Size for the Training Set

Sample Size for Training Set: The document does not provide specific information about a dedicated "training set" sample size. For IVD reagents like this, the development process typically involves internal validation and optimization using various samples, but these are not usually formally termed "training sets" in the same way as machine learning algorithms. The performance assessment data N=50 likely represents a portion of the validation data.

9. How Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: As mentioned above, the concept of a "training set" and its explicit ground truth establishment is not typically documented in this manner for traditional IVD reagent submissions. The device's methodology (enzyme immunoassay) is based on established biochemical principles. Ground truth for optimizing and calibrating such a reagent would be derived from:
- Known concentration standards: Using commercially prepared or internally validated standards with defined T Uptake values.
- Reference materials: Using biological samples with assigned values from reference laboratories or methods.
- Comparison to existing, validated methods: Initial development and optimization would likely involve running samples in parallel with accepted methods to ensure the new reagent provides accurate and reliable results.

Overall, the study demonstrates substantial equivalence to the predicate device by showing comparable assay range, precision, and a strong correlation with both the predicate and another commercial T Uptake assay.

Summary

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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: (973) 882-8630

Contact Person

Steven Dalessio Manager, Quality Assurance/Regulatory Affairs Phone: (973) 882-8630

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[510(k) Number K951586]

Device Description

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 ofunsaturated binding sites on thethyroid-binding proteins	Quantitative determination ofunsaturated binding sites onthe thyroid-binding proteins
Methodology	Enzyme immunoassay	Enzyme immunoassay
ReagentsReagent 1Volume	Liquid; Enzyme conjugate210 µL	Liquid; Enzyme conjugate210 µL
Reagent 2Volume	Liquid; Antibody/Substrate70 µL	Liquid; Antibody/Substrate70 µL
SpecimenTypeVolume	Serum and plasma9 µL	Serum9 µL
Assay SystemReagent 1 + SampleReagent 2Temperature	Incubate 288 secRead 120 to 192 sec (12 sec intervals)37 °C	Incubate 240 secRead 63 and 273 sec37 °C
Detection MethodTypeWavelength, nm	SpectrophotometricBichromatic: 340/415	SpectrophotometricBichromatic: 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 SummaryAssay Range	15% to 50%	15% to 50%
PrecisionWithin 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 (770) 488-7655.

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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1***1 .l	e	----	0

1375 510(k) Number (if Known):

ACE T Uptake Reagent Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

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)

Over-The-Counter Use_

彩

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1715 Triiodothyronine uptake test system.

(a)
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.(b)
Classification. Class II. 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.