QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA by INOVA DIAGNOSTICS, INC.

The QUANTA Lite™ SLA (soluble liver antigen) kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-SLA (soluble liver antigen) antibody of the IgG class in human serum. This test is intended to aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis (AIH).

Device Description

The QUANTA Lite™ SLA (soluble liver antigen) kit is an enzyme-linked immunosorbent assay (ELISA).

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the QUANTA Lite™ SLA ELISA device, not a study report. Therefore, it does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and a study proving device performance as it would typically be found in a clinical study report or a 510(k) summary.

However, based on the provided text, I can extract some relevant information and highlight what is missing.

Information Extracted from the Document:

Device Name: QUANTA Lite™ SLA (Soluble Liver Antigen) ELISA
Intended Use: Semi-quantitative detection of anti-SLA (soluble liver antigen) antibody of the IgG class in human serum, intended to aid in the diagnosis of conditions with elevated levels of anti-SLA antibody including autoimmune hepatitis (AIH).

Missing Information (and why it's missing from this type of document):

This letter is an FDA clearance, which means the manufacturer submitted data in their 510(k) application demonstrating substantial equivalence to a predicate device. The detailed study results, acceptance criteria, sample sizes, ground truth establishment, etc., would be in the 510(k) Summary or the full 510(k) submission, which is not provided here.

Therefore, I cannot populate the table or answer most of the specific questions.

Placeholder for Answer Structure, if the full 510(k) Summary were available:

Here's how I would structure the answer if the required information were present:

1. Table of Acceptance Criteria and Reported Device Performance

(This would typically outline performance metrics like Sensitivity, Specificity, Agreement with a predicate device, Precision, etc., and the thresholds set for acceptance.)

Acceptance Criteria Metric	Acceptance Threshold	Reported Device Performance	Meets Criteria?
Sensitivity	[e.g., > 90%]	[e.g., 92.5%]	Yes
Specificity	[e.g., > 95%]	[e.g., 96.8%]	Yes
Positive Agreement	[e.g., > 90%]	[e.g., 91.2%]	Yes
Negative Agreement	[e.g., > 90%]	[e.g., 95.5%]	Yes
Overall Agreement	[e.g., > 90%]	[e.g., 93.4%]	Yes
Intra-Assay Precision	[e.g., CV < 10%]	[e.g., CV < 8%]	Yes
Inter-Assay Precision	[e.g., CV < 15%]	[e.g., CV < 12%]	Yes
Cross-reactivity	[e.g., No significant cross-reactivity with x, y, z]	[e.g., Confirmed]	Yes

2. Sample size used for the test set and the data provenance

Sample Size (Test Set): [e.g., N=500 serum samples (250 positive, 250 negative)]
Data Provenance: [e.g., Retrospective, multi-center study from hospitals in the USA and Europe.]

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: [e.g., 3]
Qualifications: [e.g., Board-certified Rheumatologists/Hepatologists with 10+ years of experience in diagnosing autoimmune diseases, specifically AIH.]

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: [e.g., Consensus among all 3 experts for ground truth; if disagreement, a fourth senior expert was consulted for final decision (3+1 model).]

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

MRMC Study: No, this is an in vitro diagnostic (IVD) device (ELISA assay) for antibody detection, not an imaging AI device that assists human readers. Therefore, an MRMC study is not applicable in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Yes, an ELISA is inherently a standalone test. The performance metrics (Sensitivity, Specificity, etc.) are based on the device's ability to detect the analyte directly from the sample without human interpretation influence on the result generation, though human interpretation of the result value (e.g., comparing to a cutoff) is part of its intended use.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Ground Truth Type: [e.g., A combination of established clinical diagnosis of autoimmune hepatitis (AIH) based on International Autoimmune Hepatitis Group (IAIHG) criteria, clinical follow-up, and confirmation using a previously FDA-cleared reference method for anti-SLA antibody detection (e.g., Western blot or IFA) which served as the "gold standard" or predicate comparator.]

8. The sample size for the training set

Sample Size (Training Set): [e.g., N=1000 serum samples for initial development and optimization. Note: For IVDs, "training set" might refer more to method development/optimization than to a machine learning context.]

9. How the ground truth for the training set was established

Ground Truth (Training Set): [e.g., Similar to the test set, established using clinical diagnosis for AIH and/or predicate device results. For optimization, known positive and negative samples, as well as characterized samples with varying antibody titers, would be used.]

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Brys C. Myers Manager, Regulatory Affairs INOVA Diagnostics, Inc. 10180 Scripps Ranch Boulevard San Diego, California 92131-1234

Re: K021482

Trade/Device Name: OUANTA Lite SLA ELISA Regulation Number: 21 CFR § 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: II Product Code: NIY Dated: July 24, 2002 Received: July 25, 2002

JUL 3 0 2002

Dear Mr. Myers:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours.

Steven Sutman

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: QUANTA Lite™ SLA (Soluble Liver Antigen ) ELISA

Indications For Use:

FBA/CDRH/ODE/DMC

May 8 10 22 AM '02

RECEIVED

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

J.P. Reeves for S. Altaie

sion of Clinical 510(k) Number _

Prescription Use √
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

5'5

I
II

Regulation Number and Section

§ 866.5660 Multiple autoantibodies immunological test system.

(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).