For the qualitative and semi-quantitative detection of human antibodies to SSA nuclear antigen in human serum by enzyme immunoassay. For use as an aid in the diagnosis of systemic rheumatic disease, particularly Sjogren's Syndrome. For manual use, or for use with the HyPrep System Plus. For In Vitro Diagnostic Use Only.

For in vitro diagnostic use only. For the qualitative and semi-quantitative detection of IgG antibodies to SSA in human serum by enzyme immunoassay. For use as an aid in the diagnosis of systemic rheumatic disease, particularly Sjogren's Syndrome. For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.

Device Description

The SeraQuest Anti-SSA test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against SSA nuclear antigen (Anti-SSA) , in human serum. The Calibrators in the SeraQuest Anti-SSA test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.

AI/ML Overview

Here's an analysis of the SeraQuest® Anti-SSA device based on the provided text, focusing on acceptance criteria and the supporting study:

The provided document describes a 510(k) premarket notification for the SeraQuest® Anti-SSA device, which is an in vitro diagnostic (IVD) test. For IVDs, "acceptance criteria" usually refers to agreement or concordance rates with a legally marketed predicate device or a clinical diagnosis. The "study" here is a comparative study against a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity, specificity, or agreement. Instead, it presents the results of a comparison study with a predicate device, implying that the observed agreement rates were deemed acceptable for substantial equivalence.

Implied Acceptance Criteria and Reported Performance for SeraQuest® Anti-SSA vs. Shield Diastat Anti-SSA:

Metric	Implied Acceptance Criteria (Based on Substantial Equivalence to Predicate)	Reported Device Performance (95% CI)
Relative Sensitivity	High agreement with predicate for positive cases.	96.1% (91.8% to 100%)
Relative Specificity	High agreement with predicate for negative cases.	96.1% (93.5% to 98.8%)
Overall Agreement	High overall agreement with predicate.	93.9% (93.9% to 98.4%)

Note: The acceptance criteria are "implied" because the document states the device is "substantially equivalent in intended use and performance" to the predicate, and these performance metrics are presented in the "Summary of Clinical Testing" to support that claim.

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

Sample Size for Test Set: 288 serum specimens.
Data Provenance: The document does not explicitly state the country of origin. It also does not specify if the data was retrospective or prospective. Given the nature of a 510(k) submission for an IVD, it is common for such comparative studies to use banked or archival specimens (retrospective), but this is not explicitly stated.

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

The "ground truth" in this context is established by the predicate device, the Shield Diastat Anti-SSA test. The document does not mention:

Any human experts used to establish the ground truth for the test set.
The qualifications of any such experts.
- This is an IVD device, and the "ground truth" for evaluating its performance is its concordance with a legally marketed predicate device rather than direct expert consensus on clinical presentation or pathology.

4. Adjudication Method for the Test Set

There was no direct expert adjudication method described for the test set. The comparison was solely against the results of the predicate device (Shield Diastat Anti-SSA). Discrepancies between the two tests were noted and quantified (e.g., 8 positive by SeraQuest but negative by Shield), but there's no mention of a third-party or expert review to "adjudicate" these differences.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic (EIA) test, which is read instrumentally or visually based on a color change and threshold. It does not involve human "readers" interpreting imaging or complex patterns where an MRMC study would be applicable. The effectiveness is measured by its analytical performance (sensitivity, specificity, agreement) against a predicate device.

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

Yes, the study described is a standalone performance study of the device. As an in vitro diagnostic test, the SeraQuest Anti-SSA kit performs its function (detecting antibodies) independently of human cognitive interpretation or "in-the-loop" assistance for a diagnosis. The results are quantitative (Index values) and qualitative (Positive/Equivocal/Negative) based on the assay's biochemical reactions and photometric readings. While a human initiates the test and interprets the final numerical/categorical output, the core performance relates to the test's ability to correctly identify the presence or absence of antibodies. The comparison described is between the standalone SeraQuest device and the standalone predicate device.

7. The Type of Ground Truth Used

The primary ground truth used for the validation study was the results obtained from a legally marketed predicate device: the Shield Diastat Anti-SSA test.

The intent is to show that the new device performs comparably to an already accepted device.

8. The Sample Size for the Training Set

The document does not provide any information regarding a "training set" or its sample size. For 510(k) submissions of IVD kits, especially for enzyme immunoassays like this one, the focus is typically on the validation study demonstrating performance against a predicate or an established clinical diagnosis, rather than describing a machine learning "training set." The development process for an EIA usually involves optimization and validation steps, but these are not referred to as "training" in the sense of machine learning algorithms.

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

As no training set is mentioned, no information is available on how its ground truth was established.

Summary

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33181 Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL Page No. 125

MAY 1 2 1998

510(k) SUMMARY

Applicant:	Quest International, Inc.1938 N.E. 148th TerraceNorth Miami, FL 33181
Registration No.	1061839
Contact Person:	Robert A. Cort, V.P., Quality Assurance
Telephone:	(305) 948-8788
Telefax:	(305) 948-4876
Manufacturing Site:	Same as above
Device:	SeraQuest® Anti-SSA
Device Name:	Antinuclear antibody immunological test system (21CFR § 866.5100)

Device Classification: Class II (performance standards)

Description:

The Calibrators in the SeraQuest Anti-SSA test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.

Principle:

Diluted samples are incubated in wells coated with SSA antigen. Antibodies against SSA (if present) are immobilized in the wells. Residual sample is eliminated by washing and conjugate (enzyme-labeled antibodies to human IgG) is added and incubated. If IgG antibodies to SSA are present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and draining, and the enzyme substrate is added and incubated. In the presence of the enzyme, the substrate is converted to a yellow end-product which is read photometrically at 405 nm.

Intended Use:

For the qualitative and semi-quantitative detection of human antibodies to SSA nuclear antigen in human serum by enzyme immunoassay. For use as an aid in the diagnosis of systemic rheumatic

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disease, particularly Sjogren's Syndrome. For manual use, or for use with the HyPrep System Plus. For In Vitro Diagnostic Use Only.

Predicate Device:

The SeraQuest Anti-SSA test is substantially equivalent in intended use and performance, to the Shield Diastat Anti-SSA test, Shield Diagnostics, Dundee, DD2 1SW.

Summary of technological characteristics:

Characteristic	SeraQuest Anti-SSA	Shield Diastat Anti-SSA
Description:	Enzyme Immunoassay	Enzyme Immunoassay
Intended Use:	The detection ofantibodies against SSAin human serum.	The detection ofantibodies against SSAin human serum.
Solid Phase:	Plastic Microwell	Plastic Microwell
Antigen Source:	Calf Thymus	Calf Thymus
Number of Incubation Periods:	Three	Three
Sample Dilution:	1:50	1:500
Sample IncubationDuration:	30 minutes	60 minutes
Incubation Temperature:	Room temperature	Room temperature
Enzyme-labeled Conjugate:
Antibody	Goat anti-human IgG	Goat anti-human IgG
Enzyme	Alkaline phosphatase	Alkaline phosphatase
Conjugate Volume:	100 μl	100 μl
Conjugate IncubationDuration:	30 minutes	30 minutes
Substrate:	p-Nitrophenylphosphate	phenolthaleinmonophosphate

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... .. .

Subtrate Volume:	100 µl	100 µl
Substrate IncubationDuration:	30 minutes	30 minutes
Stop Reagent:	0.5 M Trisodiumphosphate	SodiumHydroxide
Stop Reagent Volume:	100 µl	100 µl
Readout:	Spectrophotometric405 nm	Spectrophotometric540-565 nm

Summary of Clinical Testing:

Of the 288 specimens tested, 74 were positive, and 200 were negative in both the SeraQuest and Shield tests (please see Table C-3). Of the remaining specimens which were negative by the Shield test, 8 were positive and 2 equivocal by the SeraQuest test; 4 specimen which were positive by the Shield test, one was equivocal and 3 negative in the SeraQuest test. Refer to table 1 below.

TABLE 1.

RESULTS OF SeraQuest Anti-SSA ASSAYS AND SHIELD Anti-SSA ASSAYS OF 288 SERUM SPECIMENS.

SeraQuest ANTI-SSA

Shields ANTI-SSA

	Positive	Equivocal	Negative		%	95% CI*
Positive	74	1	3	Relative sensitivity√	96.1	91.8 to 100
Negative	8	2	200	Relative specificity√Overall agreement√	96.1	93.5 to 98.893.9 to 98.4

イ Excluding equivocal results.
★ Calculated by the exact method.
** Calculated by the normal method.

Reference: Gardner, M.J. and Altman, D.G., Confidence Intervals Rather Than Hypothesis Testing. Brit. Med. J., 292: 746-750. 1986.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 2 1998

Robert A. Cort Vice President, Quality Assurance QUEST INTERNATIONAL, INC. 1938 N.E. 148th Terrace North Miami, FL 33181

Re: K980810 Trade Name: SeraQuest® Anti-SSA Regulatory Class: II Product Code: LJM Dated: April 28, 1998 Received: April 28, 1998

Dear Mr. Cort:

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 to legally marketed predicate 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 of the Act. The general controls provisions 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 Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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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Page 2 -

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/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

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Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181

APPENDIX 8

Page of

510(k) Number (if known): _

Device Name: __SeraQuest Anti-SSA

Indications For Use:

For in vitro diagnostic use only. 1.
For the qualitative and semi-quantitative detection of IgG antibodies to SSA in 2. human serum by enzyme immunoassay.
1. For use as an aid in the diagnosis of systemic rheumatic disease, particularly Sjogren's Syndrome.
For manual use, or for use with the HyPrep System Plus semi-automated fluid 4. handler.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	1988810

Prescription Use	✓
(Per 21 CFR 801.109)

Over-The-Counter Use
(Optional Format 1-2-96)

Regulation Number and Section

§ 866.5100 Antinuclear antibody immunological test system.

(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).