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

Device Description

Liquichek ANA Control, Speckled Pattern is prepared from human serum with added preservatives and stabilizers. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.

AI/ML Overview

The provided document is a 510(k) summary for the Bio-Rad Liquichek ANA Control, Speckled Pattern. It describes the device, its intended use, and claims substantial equivalence to another legally marketed device. However, it does not include information about a study that proves the device meets specific acceptance criteria in the manner typically associated with clinical performance studies for diagnostic devices.

The document focuses on demonstrating substantial equivalence for regulatory approval, rather than detailing a performance study with acceptance criteria and results.

Therefore, many of the requested sections about acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement cannot be extracted from the provided text because such a detailed study is not presented.

Here's what can be extracted and inferred based on the document's content:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance. The "acceptance criteria" here are implicitly tied to demonstrating performance comparable to the predicate device in the characteristics listed in the comparative table.
Reported Device Performance: The document doesn't provide numerical performance metrics (e.g., sensitivity, specificity, accuracy) for the Liquichek ANA Control. Instead, it compares its characteristics to a predicate device.

Characteristic	Predicate Device (Kallestad Quantafluor Autoantibody Positive Control)	Bio-Rad Liquichek ANA Control, Speckled Pattern	Performance/Comparison
Intended Use	Autoantibody positive control for Kallestad Quantafluor Fluorescent Autoantibody Test	Unassayed quality control serum for monitoring indirect immunofluorescent testing of antinuclear antibodies (ANA)	Similar Scope: Both are controls for autoantibody testing. Bio-Rad is more general for ANA.
Form	Lyophilized	Liquid	Different: Convenience difference.
Matrix	Human Serum	Human Serum	Identical
Levels	Positive	Negative, Positive, High Positive	Improved: Broader range of control levels.
Storage	2-8°C	2-8°C	Identical
Analytes	ANA (Centromere, SSA, SSB, Scl-70, Sm, RNP, Spindle, Nucleolar), AMA, ASMA, APCA, Anti-nDNA	ANA (Speckled Pattern)	Different/More Specific: Bio-Rad focuses on a specific ANA pattern.
Open Vial Claim	6 weeks at 2-8°C, 4 months at -20°C	30 Days at 2-8°C	Different: Shorter open vial stability at 2-8°C.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not provided. The document does not describe a "test set" in the context of a clinical performance study with patient samples. The comparisons are based on device characteristics, not an evaluation against a clinical dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable/Not provided. No "test set" requiring expert ground truth is described.

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

Not applicable/Not provided. No "test set" requiring adjudication is described.

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:

No. This device is a quality control reagent, not an AI or imaging diagnostic device that would be subject to MRMC studies.

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

No. This device is a quality control reagent, not an algorithm.

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

Not applicable/Not provided. The "ground truth" for a quality control is its known concentration/characteristics. The document implies the product is manufactured to contain specific ANA (Speckled Pattern) reactivity, which serves as its intrinsic "ground truth" for quality control purposes, but doesn't detail external validation studies against clinical ground truth.

8. The sample size for the training set:

Not applicable/Not provided. This is not an AI device, so there's no "training set."

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

Not applicable/Not provided. This is not an AI device.

In summary: The provided document is a regulatory submission for a quality control product, emphasizing its characteristics and substantial equivalence to a predicate device, rather than a clinical performance study with acceptance criteria for a diagnostic algorithm.

Summary

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DEC 1 8 1998

Image /page/0/Picture/14 description: The image shows the logo for BIO-RAD. The logo is in black and white, with the words "BIO" and "RAD" in large, bold letters. The plus sign is between the two words. The logo is surrounded by a black border. The date DEC 16 1986 is at the top of the image.

Bio-Rad Laboratories

California 92618-2011 Telephone: (949) 598-1200

510(k) Summary

Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA (949)598-1285 Fax (949)598-1555

Contact Person Elizabeth Platt

Date of Summary Preparation December 8, 1998

Device (Trade & Common Name) Liquichek ANA Control, Speckled Pattern

Classification Name Class II, 82DHN CFR 866.5100: Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control.

Devices to Which Substantial Equivalence is Claimed Kallestad Quantafluor Autoantibody Positive Control Sanofi Diagnostics Pasteur Chaska, Minnesota K813592

Statement of Intended Use

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

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Image /page/1/Picture/0 description: The image shows the logo for BIO-RAD. The logo is in white text on a black background. The text is bold and sans-serif.

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

Description of the Device

Statement of How Technological Characteristics Compare to Substantial Equivalent Device

A table is provided below comparing the similarities between the Bio-Rad Liquichek ANA Control, Speckled Pattern and the device to which substantial equivalence is claimed.

	Kallestad Quantafluor Autoantibody PositiveControl	Bio-Rad LiquichekANA Control, Speckled Pattern
Intended Use	Autoantibody positive control for KallestadQuantafluor Fluorescent Autoantobody Testwith mouse kidney, mouse stomach/kidney,Hep-2 cell line, or Crithidia luciliae substrates.	An unassayed quality controlserum for monitoring indirectimmunofluorescent testing ofantinuclear antibodies (ANA).
Form	Lyophilized	Liquid
Matrix	Human Serum	Human Serum
Levels	Positive	Negative, Positive, HighPositive
Storage	2-8°C	2-8°C
Analytes	ANA (Centromere, SSA, SSB, Scl-70, Sm,RNP, Spindle, Nucleolar)AMAASMAAPCAAnti-nDNA	ANA (Speckled Pattern)
Open VialClaim	6 weeks at 2-8°C4 months at -20°C	30 Days at 2-8°C

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three overlapping profiles, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 1 8 1998

Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA 92618

Re: K984400

Trade Name: Liquichek ANA Control, Speckled Pattern, Model 202 Regulatory Class: II Product Code: DHN Dated: December 8, 1998 Received: December 9, 1998

Dear Ms. Platt:

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 (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). 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 Ouality 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.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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Page 1 of 1

510(k) Number: _______________________________________________________________________________________________________________________________________________________________ Device Name: Liquichek ANA Control, Speckled Pattern

Indications for Use:

Liquichek ANA Control, Speckled Pattern 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-CONTINUE ON ANOTHER PAGE IF NEEDED)

(Concurrence of CDRH, Office of Device Evaluation)

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

Prescription Use		OR	Over-The Counter Use
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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).