The Liquichek™ ANA Control, Nucleolar 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 study information for the Liquichek™ ANA Control Nucleolar Pattern, Positive device, based on the provided text:

Acceptance Criteria and Device Performance

This submission focuses on establishing the stability claims for a quality control material. Therefore, the "acceptance criteria" are the stability periods claimed by the manufacturer, and the "reported device performance" is the confirmation that these stability periods were met in the studies.

Acceptance Criteria (Target)	Reported Device Performance (Achieved)
Opened Vial Stability: Stable for 60 days when stored tightly capped at 2 to 8°C.	The analyte is stable for 60 days when the control is opened and stored tightly capped at 2 to 8°C.
Shelf Life (Unopened): 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.

Note: The document explicitly states that "Real time studies will be ongoing to support the shelf life of this product," indicating that the 2-year shelf life claim might be based on accelerated stability studies or early real-time data, with full real-time data still being collected.

Study Details

Based on the provided text, the study focuses on product stability. Information regarding analytical performance (e.g., sensitivity, specificity, accuracy) would typically be relevant for diagnostic devices that are intended to measure an analyte. As this is a quality control device, the primary "performance" is its stability and ability to maintain its characteristics over time.

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in terms of number of vials or batches tested. The study involves assessing the control material's stability over time.
- Data Provenance: Not explicitly stated, but assumed to be internal laboratory studies conducted by Bio-Rad Laboratories in the USA, where the submitter is located. The studies are described as "stability studies." They are likely prospective in nature, as they involve monitoring the product over time to define stability claims.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. For a quality control material's stability study, "ground truth" is typically established by objective measurements of the analyte's presence and pattern (in this case, ANA Nucleolar Pattern) at various time points, compared to initial measurements. This doesn't involve human expert interpretation in the same way a diagnostic imaging study would. The analysis would be performed by trained laboratory personnel following established protocols.
Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like "2+1" are relevant for resolving discrepancies in human expert interpretations (e.g., in an imaging study). For a stability study, the performance is measured objectively, and statistical methods (e.g., comparing measurements to acceptance limits) would be used to determine if the product remains stable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic interpretation tasks. The Liquichek™ ANA Control is a quality control material, not a diagnostic AI system.
Standalone Performance Study:
- Yes, a standalone study was essentially performed. The stability studies evaluate the performance of the control material (its ability to maintain the ANA Nucleolar Pattern) independently, over time, without human intervention as a variable in the stability assessment itself. The "algorithm" here is the inherent chemical and biological stability of the control material.
Type of Ground Truth Used:
- The "ground truth" for the stability study is the inherent characteristic of the control (presence of ANA Nucleolar Pattern reactivity) as measured at baseline and validated against established laboratory standards for ANA testing. Over time, subsequent measurements are compared against this initial "truth" to ensure the pattern and reactivity are maintained within acceptable limits. This would involve specific laboratory assays (indirect immunofluorescence) and objective assessment of the fluorescence pattern.
Sample Size for the Training Set:
- Not applicable. This device is a quality control material, not an AI or machine learning model that requires a "training set."
How the Ground Truth for the Training Set Was Established:
- Not applicable, as explained above.

Summary

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KO24229

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

1.0 Submitter

JAN 1 5 2003

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

3.0 Device to Which Substantial Equivalence is Claimed

Kallestad™ Autoantibody Positive Control 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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Statement of Intended Use 5.0

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

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:

Kallestad™ Autoantibody Positive Control Bio-Rad Laboratories

510 (k) Number: K792610

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

Characteristics	Liquichek™ ANA Control,Nucleolar Pattern, Positive(New Device)	Kallestad™ Autoantibody PositiveControl(Predicate Device)
Similarities
Intended Use	The Liquichek™ ANA Control,Nucleolar Pattern, Positive, isintended for use as an unassayedquality control to monitor indirectimmunofluorescent testing ofantinuclear antibodies (ANA).	The Autoantibody Positive Controlis a replacement reagent in theKallestad FluorescentAutoantibody test with mousekidney, mouse stomach/kidney,Hep-2 cell line, or Crithidia luciliaesubstrates.
Matrix	Human Serum	Human Serum
Storage(Unopened)	2°C to 8°Cuntil expiration date	2°C to 8°Cuntil expiration date
Form	Liquid	Liquid

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Differences
Stability(Opened)	Once opened the analyte will be stable for 60 days.	No claim for stability
Analyte	ANA Nucleolar Pattern	ANA: Centromere Pattern, SSA, SSB, Scl-70, Sm, RNP, Spindle Pattern, Nucleolar PatternAMAASMAAPCAAnti-nDNA

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, Nucleolar 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 Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of a human figure with three lines extending from the head.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 5 2003

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

K024229 Trade/Device Name: Liquichek 114 ANA Control. Nucleolar 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:

Re:

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 A.ct. 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 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,

iteven 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): K034229

Device Name: Liquichek™ ANA Control, Nucleolar Pattern, Positive

Indications for Use:

The Liquichek™ ANA Control, Nucleolar 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)

V Prescription use or

Over-the Counter use

A. Reeves for J. Bautista

(Division Sign-Off) Division of Clinical Labora 510(k) Number -

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).