Liquichek Anti-Scl-70 Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of Scl-70 autoantibodies.

Device Description

Liquichek Anti-Scl-70 Control, ElA 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 text is a 510(k) summary for the Bio-Rad Liquichek Anti-Scl-70 Control, EIA. This document is a premarket notification to the FDA for a new medical device, demonstrating its substantial equivalence to a legally marketed predicate device.

Crucially, this document is for a quality control device, not a diagnostic device that detects a disease in a patient. As such, the typical acceptance criteria and study designs associated with diagnostic accuracy (e.g., sensitivity, specificity, clinical outcome studies) are not applicable here.

The "acceptance criteria" for a quality control device typically refer to its performance characteristics in monitoring an assay, such as stability, consistency, and expected range of values. The "study that proves the device meets the acceptance criteria" for a quality control product is usually an internal validation demonstrating these characteristics.

Based on the provided text, here's a breakdown of what can be inferred:

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

The document implicitly defines "acceptance criteria" by comparing the characteristics of the new device (Liquichek Anti-Scl-70 Control, EIA) to its predicate device (Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit). The goal is to show substantial equivalence, meaning the new device performs similarly and is as safe and effective for its stated intended use.

Characteristic	Acceptance Criteria (Implied by Predicate Device)	Reported Device Performance (Liquichek Anti-Scl-70 Control, EIA)
Intended Use	A qualitative enzyme immunoassay (EIA) for screening the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain systemic rheumatic diseases.	An unassayed quality control serum for monitoring enzyme immunoassay procedures for the detection of Scl-70 autoantibodies.
Form	Liquid	Liquid
Matrix	Human Serum	Human Serum
Levels	Negative, Positive, Cutoff	Negative, Positive, High Positive
Storage	2-8°C	2-8°C
Analytes	Total ANAs against: DNA (dsDNA, nDNA), Histones, SS-A/Ro, SS-B/La, Sm, SmRNP, Scl-70, Jo-1, Centrometric antigens, Sera positive for Immunofluorescent (IFA) Hep-2 ANAs	Anti-Scl-70
Open Vial Claim	Shelf life (general)	30 Days at 2-8°C

Important Note: The "acceptance criteria" here are not numerical performance targets like sensitivity/specificity. Instead, they are the structural and functional equivalence to the predicate device, for its role as a quality control. The key difference in "Intended Use" and "Analytes" highlights that while the new device is a control for a subset of what the predicate detects, it serves a similar function within the broader immunoassay context (monitoring).

The study that "proves" the device meets these criteria is the submission itself, which articulates these similarities to the FDA. For a quality control device, this typically involves internal validation testing by the manufacturer to ensure:

The control material is stable and maintains its intended characteristics over its claimed shelf life (including open vial stability).
It produces consistent and predictable results within the specified assay conditions.
It can effectively monitor the performance of an anti-Scl-70 EIA.

The document does not provide details of these internal validation studies (e.g., specific protocols, raw data, or statistical analyses of stability or consistency). It simply states the characteristics.

The remaining information points are not directly applicable to a 510(k) submission for a quality control device and the level of detail provided in this type of regulatory document. This is because:

2. Sample size used for the test set and the data provenance: Not applicable. There isn't a "test set" of patient samples in the way there would be for a diagnostic device. The "testing" would involve internal validation of the control material itself.
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. Ground truth for a quality control material is established by its manufacturing process and characterization, not by expert interpretation of patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 is for AI-assisted diagnostic tools, not quality control reagents.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is for AI algorithms, not a chemical control.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For a quality control, the "ground truth" is its precisely characterized composition and reactivity, established by the manufacturer's own assays and reference methods. It's an internal standard, not an external clinical marker.
8. The sample size for the training set: Not applicable. There is no "training set" for a quality control material in the context of machine learning.
9. How the ground truth for the training set was established: Not applicable for the same reason.

In summary, this 510(k) document establishes substantial equivalence for a quality control product by demonstrating similar characteristics and intended use to a predicate quality control product. The detailed performance studies typically seen for diagnostic devices (especially those involving AI) are not present or required here.

Summary

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Bio-Rad Laboratories iannstics Groun 00 Jeronimo Road ne, California 92618-2017 lephone: (949) 598-1200

1984475

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 Jecember 14, 1998

Device (Trade & Common Name) Liquichek Anti-Scl-70 Control, EIA

Classification Name Class II, 82LKJ CFR 866.5100: Antinuclear Antibody, Antigen, Control.

Devices to Which Substantial Equivalence is Claimed Helix Enzyme Immunoassay Antinuclear Antibody Screening Test Kit Helix Diagnostics West Sacrament, California K954723

Statement of Intended Use

Liquichek Anti-Scl-70 Control, ElA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of Scl-70 autoantibodies.

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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 Anti-Scl-70, ElA and the device to which substantial equivalence is claimed.

	Helix Enzyme Immunoassay AntinuclearAntibody Screening Test Kit	Bio-Rad Liquichek Anti-Scl-70Control, EIA
Intended Use	A qualitative enzyme immunoassay (EIA) forscreening the presence of antinuclearantibodies (ANAs) in human serum as an aidin the diagnosis of certain systemic rheumaticdiseases.	An unassayed quality controlserum for monitoring enzymeimmunoassay procedures forthe detection of Scl-70autoantibodies.
Form	Liquid	Liquid
Matrix	Human Serum	Human Serum
Levels	Negative, Positive, Cutoff	Negative, Positive, High Positive
Storage	2-8°C	2-8°C
Analytes	Total ANAs against:DNA (dsDNA, nDNA)HistonesSS-A/RoSS-B/LaSmSmRNPScl-70Jo-1Centrometric antigensSera positive for Immunofluorescent(IFA) Hep-2 ANAs	Anti-Scl-70
Open VialClaim	Shelf life	30 Days at 2-8°C

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DEC 22 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Elizabeth Platt Staff Regulatory Affairs Representative BIO-RAD LABORATORIES 9500 Jeronimo Road Irvine, CA 92618-2017

Re: K984475 Trade Name: Liquichek Anti-Scl-70 Control, EIA Model #212 Regulatory Class: II Product Code: LKJ December 14, 1998 Dated: Received: December 16, 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 Quality 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlations.

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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) Additionally, for questions on the promotion and 594-4588. 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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: K 984475 Device Name: Liquichek Anti-Scl-70 Control, ElA

Indications for Use:

Liquichek Anti-Scl-70 Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of Anti-Scl-70 autoantibodies.

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

(Concurrence of CDRH, Office of Device Evaluation)

Teta E Makin

(Division Sign-Off)

Division of Clinical Laboratory Devices	K984475
510(k) Number

Prescription Use	✓	OR	Over-The Counter Use	1
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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).