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.

Device Description

The ACE® T4 Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Coniugate reagent. The assay uses 8-anilino-1-naphthalene sulfonic acid (ANS) to dissociate 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.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ACE® T4 Reagent are implicitly defined by its substantial equivalence to the predicate device, the DRI Thyroxine (T4) Enzyme Immunoassay. The reported device performance is compared directly to the predicate device's performance characteristics.

Parameter	Acceptance Criteria (Predicate Device)	Reported Device Performance (ACE® T4 Reagent)
Assay Range	0.7 µg/dL to 20 µg/dL	0.47 µg/dL to 20 µg/dL
Precision
- Within Run	5.4 %CV	3.7 %CV
- Between Run	4.3 %CV	4.6 %CV
Correlation vs	Commercial thyroxine assay	Hitachi 717
- Slope	1.02	1.070
- Intercept	-0.63	-0.405
- r	0.993	0.9824
- N	108	50

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size (Correlation Study):
- Predicate Device: 108 samples (N=108)
- Proposed Device: 50 samples (N=50)
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the context of a 510(k) submission for an in-vitro diagnostic, it is generally assumed to be prospective clinical studies or laboratory studies conducted in a controlled environment as part of performance validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This document describes an in-vitro diagnostic (IVD) device for quantitative determination of thyroxine in human serum. For such devices, "ground truth" is typically established by reference methods or validated comparative assays, rather than expert consensus on images or clinical assessments. The comparison is made against existing commercial thyroxine assays (for the predicate) and the Hitachi 717 analyzer (for the proposed device). Therefore, the concept of "experts" to establish ground truth as would be relevant for image-based diagnostic aids does not directly apply here. The expertise lies in the established accuracy and reliability of the comparative analytical methods.

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, the ground truth is established by comparative analytical methods, not by human adjudication of observations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is an in-vitro diagnostic reagent, not an imaging device or an AI-assisted diagnostic tool that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this is effectively a standalone performance study. The device (ACE® T4 Reagent) is an analytical tool that quantitatively determines thyroxine levels. Its performance (precision and correlation) is evaluated directly, without human interpretation of results as part of the primary measurement.

7. The Type of Ground Truth Used

The ground truth for the test set (correlation study) was established by:

For the predicate device: A "Commercial thyroxine assay."
For the proposed device: The "Hitachi 717" analyzer, which itself is a widely accepted clinical chemistry analyzer.

This is a form of comparative assay reference method or reference instrument data used to establish equivalency and accuracy for IVDs.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning, as this device is a reagent for an enzyme immunoassay, not an AI software. The performance assessment section focuses on validation data (precision and correlation).
For traditional IVDs, "training" might refer to the development and optimization of the assay itself using various samples, but specific sample sizes for such a "training set" are not typically reported in 510(k) summaries in this manner, nor are they relevant in the same way as for AI/ML models.

9. How the Ground Truth for the Training Set Was Established

Not applicable in the context of machine learning. The "ground truth" for developing a chemical assay typically involves using calibrators and control materials with known concentrations, or comparing against established reference methods during the assay development phase. These details are not provided in this 510(k) summary.

Summary

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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: (973) 882-8630

Contact Person

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

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[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) EnzymeImmunoassay	ACE® T4 Reagent
Reference No.	K944703	TBD
Analyte	Thyroxine	Thyroxine
Intended Use	Quantitative determination ofthyroxine	Quantitative determination ofthyroxine
Methodology	Enzyme immunoassay	Enzyme immunoassay
ReagentsReagent 1Volume	Liquid; Antibody/Substrate210 µL	Liquid; Antibody/Substrate210 µL
Reagent 2Volume	Liquid; Enzyme conjugate70 µL	Liquid; Enzyme conjugate70 µL
SpecimenTypeVolume	Serum and plasma5 µL	Serum5 µL
Assay SystemReagent 1 + SampleReagent 2Temperature	Incubate 288 secRead 72 to 132 sec (12 sec intervals)37 °C	Incubate 240 secRead 63 and 203 sec37 °C
Detection MethodTypeWavelength, nm	SpectrophotometricBichromatic: 340/415	SpectrophotometricBichromatic: 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 SummaryAssay RangePrecisionWithin RunBetween Run	0.7 µg/dL to 20 µg/dL5.4 %CV4.3 %CV	0.47 µg/dL to 20 µg/dL3.7 %CV4.6 %CV
Correlation vsSlopeInterceptrN	Commercial thyroxine assay1.02-0.630.993108	Hitachi 7171.070-0.4050.982450

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 (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 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 (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 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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l of Page 1

Labels	Values
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)
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Division of Clinical Laboratory Devices

510(k) Number	K981377
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(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_

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(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1700 Total thyroxine test system.

(a)
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.(b)
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.