The Liquichek ANA Control, Homogeneous Pattern, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).

Device Description

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

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Liquichek™ ANA Control Homogeneous Pattern, Positive, based on the provided document:

This document describes a medical device, specifically a quality control material for laboratory tests, rather than a diagnostic device that performs analysis or diagnosis. Therefore, many of the typical acceptance criteria and study elements for diagnostic devices (like sensitivity, specificity, reader studies, etc.) do not apply. This submission is focused on demonstrating the stability and intended use of the control and its substantial equivalence to an existing product.

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria (from the document's "Product claims")	Reported Device Performance
Open vial stability: Analyte stable for 60 days when stored tightly capped at 2 to 8°C.	Stability studies determined the analyte is stable for 60 days when stored tightly capped at 2 to 8°C.
Shelf life: Control stable for 2 years when stored unopened at 2 to 8°C.	The control is stable for 2 years when stored unopened at 2 to 8°C.

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

Sample Size: The document does not specify a numerical "sample size" for the stability studies in the way a diagnostic study would. Instead, it refers to "stability studies" performed on the product itself.
Data Provenance: The studies were performed by Bio-Rad Laboratories. The location is Irvine, California, USA. The studies are prospective as they are "real time studies" conducted to determine shelf life and open-vial stability.

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

This question is not applicable to this type of device. As a quality control material, its "ground truth" is its inherent stability over time under specified conditions, not an interpretation by experts. The performance is assessed against predefined stability metrics (e.g., maintaining its intended reactivity as a positive control). Validation would typically involve laboratory testing, not expert consensus.

4. Adjudication Method for the Test Set

Not applicable. There is no "adjudication" in the context of stability testing for a quality control material. Performance is measured against predefined chemical or biological stability parameters.

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 device is a quality control material, not an AI-powered diagnostic device or an assistive technology for human readers. No MRMC study was conducted or is relevant.

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

Not applicable. This device is a biochemical control material, not an algorithm or an AI system.

7. The Type of Ground Truth Used

For the stability studies, the "ground truth" is the demonstrated functional stability of the control material over specified periods (60 days open, 2 years unopened) when stored under controlled conditions. This would be established through laboratory assays confirming the control continues to elicit a positive, homogeneous ANA pattern.

8. The Sample Size for the Training Set

Not applicable. This device is a quality control material, not a machine learning algorithm that requires a training set.

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

Not applicable. As stated above, there is no training set for this type of device.

Summary

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JAN 1 5 2003

K024221

Summary of Safety and Effectiveness Liquichek™ ANA Control Homogeneous Pattern, Positive

1.0 Submitter

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

Contact Person

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

Date of Summary Preparation

December 20, 2002

2.0 Device Identification

Product Trade Name:	Liquichek™ ANA Control Homogeneous Pattern,Positive
Common Name:	Antinuclear Antibody, Indirect Immunofluorescent,Antigen, Control
Classifications:	Class II
Product Code:	82DHN
Regulation Number:	21 CFR 866.5100

Device to Which Substantial Equivalence is Claimed 3.0

Kallestad ™ ANA Positive Control Homogeneous Pattern Bio-Rad Laboratories

510 (k) Number: K792610

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 ANA Control, Homogeneous Pattern, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).

6.0 Comparison of the new device with the Predicate Device

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

Kallestad™ ANA Positive Control Homogeneous Pattern Bio-Rad Laboratories

510 (k) Number: K792610

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

Characteristics	Liquichek™ ANA ControlHomogeneous Pattern, Positive	Kallestad™ ANA Positive ControlHomogeneous Pattern
	(New Device)	(Predicate Device)
Similarities
Intended Use	The Liquichek ANA Control,Homogeneous Pattern, Positive,is intended for use as anunassayed quality control tomonitor indirectimmunofluorescent testing ofantinuclear antibodies (ANA).	The intended use of the ANAPositive Control HomogeneousPattern is the quality control ofindirect fluorescent antibodyprocedures for the detection andsemi-quantitation of humanautoantibodies to nuclear antigens(ANA).
Matrix	Human Serum	Human Serum
Storage(Unopened)	2°C to 8°Cuntil expiration date	2°C to 8°Cuntil expiration date
Analyte	ANA Homogeneous Pattern	ANA Homogeneous Pattern
Form	Liquid	Liquid
Differences
Stability(Opened)	Once opened the analyte will bestable for 60 days.	No claim for stability

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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™ ANA Control Homogeneous Pattern, Positive. Product claims are as follows:

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

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 features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol in a circular fashion. The logo is black and white.

JAN 1 5 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K024221

Trade/Device Name: Liquichek™ ANA Control Homogeneous Pattern, Positive Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: DHN 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.

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).

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Page 2 -

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 Sutman

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

Enclosure

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510 (k) Number (if known): K02 422 |

Device Name: Liquichek™ ANA Control Homogeneous Pattern, Positive

Indications for Use:

The Liquichek ANA Control, Homogeneous Pattern, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use or

Over-the Counter use__________________________________________________________________________________________________________________________________________________________

J. Reeves for J. Bautista
Division Sign-Off

Division of Clinical Laboratory Devices

510(k) Number_ << 0 2 4 2 4 2 2 |

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).