Liquichek Anti-Sm Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of Smith (Sm) autoantibodies.

Device Description

This product is prepared from human serum with added preservatives. The control is provided in liquid form for convenience.

AI/ML Overview

This document is a 510(k) premarket notification for a quality control device, the Liquichek™ Anti-Sm Control, Positive. It's important to understand that 510(k) submissions typically demonstrate substantial equivalence to a predicate device, rather than proving direct clinical performance or effectiveness against a disease state in the way a pharmaceutical trial might.

Therefore, many of the typical acceptance criteria and study designs associated with direct diagnostic or therapeutic devices, such as multi-reader multi-case studies, effect sizes of AI assistance, or standalone algorithm performance, are not applicable here. This document focuses on the stability and characteristics of the control material itself.

Here's the breakdown of the information requested, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are related to its stability and its ability to function as an unassayed quality control material, demonstrating substantial equivalence to a previously cleared predicate device.

Acceptance Criteria	Reported Device Performance
Open Vial Stability	Analyte stable for 60 days when stored tightly capped at 2-8°C.
Shelf Life (Unopened)	Control stable for 2 years when stored unopened at 2-8°C.
Substantial Equivalence to Predicate	Demonstrated through comparison of characteristics (matrix, storage, form, analyte, value assignment, intended use, stability).

Study Details

Sample Size used for the test set and the data provenance:
- The document does not explicitly state a "test set" in the context of diagnostic accuracy. The studies performed were stability studies.
- Data Provenance: Not specified, but the studies were conducted internally by Bio-Rad Laboratories. The data is retained "on file at Bio-Rad Laboratories." This implies internal, retrospective testing of the control material itself rather than patient-derived data from any specific country.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a quality control material, not a diagnostic test that generates ground truth about patient conditions. The "ground truth" here is the established stability of the control material based on internal lab testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As above, this is not a diagnostic device requiring expert adjudication of results.
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:
- No. This is a quality control material, not an AI-powered diagnostic device. An MRMC study is completely irrelevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a biological quality control reagent, not an algorithm or software device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the stability studies would be the measured concentration/reactivity of the Anti-Sm analyte within the control over time, under specified storage conditions, compared to initial measurements. These measurements are performed using laboratory assays, not expert consensus or pathology on patient samples.
The sample size for the training set:
- Not applicable. This device does not use a "training set" in the context of an algorithm or machine learning. Its manufacturing and testing follow established quality control procedures.
How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set" for this type of device.

Summary

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KO24219

Summary of Safety and Effectiveness Liquichek™ Anti-Sm Control, Positive

JAN 1 5 2003

1.0 Submitter

Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1555 Fax:

Contact Person

Yvette Lloyd Senior Requlatory Affairs Specialist Telephone: (949) 598-1465

Date of Summary Preparation

December 20, 2002

2.0 Device Identification

Product Trade Name:	Liquichek™ Anti-Sm Control, Positive
Common Name:	Anti-Sm Antibody, Antigen and Control
Classifications:	Class II
Product Code:	82LKP
Regulation Number:	21 CFR 866.5100

3.0 Device to Which Substantial Equivalence is Claimed

Liquichek™ Anti-Sm Control, EIA Bio-Rad Laboratories

510 (k) Number: K984479

4.0 Description of Device

This product is prepared from human serum with added preservatives. The control is provided in liquid form for convenience.

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5.0 Statement of Intended Use

The Liquichek™ Anti-Sm Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of Smith (Sm) autoantibodies.

Comparison of the new device with the Predicate Device 6.0

This control is substantially equivalent to the following quality control material for autoimmune analysis that is currently in the market:

Liquichek™ Anti-Sm Control, EIA Bio-Rad Laboratories

510 (k) Number: K984479

Table 1. Similarities and Differences between new and predicate device.

Characteristics	Liquichek™ Anti-Sm Control,Positive(New Device)	Liquichek™ Anti-Sm Control, EIA(Predicate Device)
Similarities
Matrix	Human Serum	Human Serum
Storage(Unopened)	2°C to 8°Cuntil expiration date	2°C to 8°Cuntil expiration date
Form	Liquid	Liquid
Analyte	Anti-Sm	Anti-Sm
ValueAssignment	Unassayed	Unassayed
Differences
Intended Use	The Liquichek™ Anti-Sm Control,Positive, is intended for use as anunassayed quality control tomonitor indirectimmunofluorescent testing for thedetection of Smith (Sm)autoantibodies.	The Liquichek™ Anti-Sm Control,EIA is intended for use as anunassayed quality control tomonitor enzyme immunoassayprocedures for the detection ofSmith (Sm) autoantibodies.
Stability(Opened)	Once opened the analyte will bestable for 60 days.	Once opened the analyte will bestable for 30 days.

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7.0 Summary of Performance Data

Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Anti-Sm Control, Positive. Product claims are as follows:

Once the control is opened the analyte will be stable for 60 days when 7.1 stored tightly capped at 2 to 8°C.
7.2 The control is stable for 2 years when stored unopened at 2 8ºC.

Real time studies will be ongoing to support the shelf life of this product.

All supporting data is retained on file at Bio-Rad Laboratories.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 5 2003

Ms. Yvette Lloyd Senior Regulatory Affairs Specialist Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, California 92618-2017

Re: K024219

Trade/Device Name: Liquichek™ Anti-Sm Control, Positive Regulation Number: 21 CFR § 866.5100 Regulation Name: Anti-Sm Antibody, Control Regulatory Class: II Product Code: LKP Dated: December 20, 2002 Received: December 23, 2002

Dear Ms. Lloyd:

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. Iisting 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2

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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutmess

Steven I. Gutman, M.D., M.B. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K024219 510 (k) Number (if known):_

Device Name: Liquichek™ Anti-Sm Control, Positive

Indications for Use:

Liquichek Anti-Sm Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of Smith (Sm) autoantibodies.

(PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

V Prescription use or

Over-the Counter use

J. Reeves for J. Bautista
(Division Signee)

Division of Clinical Laboratory Devices

510(k) Number - KO 2 4219

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).