(6 days)
Liquichek Anti-Jo-1 Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of Jo-1 autoantibodies.
Liquichek Anti-Jo-1 Control, EIA 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.
The provided text is a 510(k) summary for the Bio-Rad Liquichek Anti-Jo-1 Control, EIA. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically expected for a performance study evaluating a new diagnostic algorithm or device's accuracy.
This document is a regulatory submission for a quality control product, not a diagnostic test with performance metrics like sensitivity, specificity, or AUC. Therefore, many of the requested categories (like sample size for test/training set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or not provided in this context.
Based on the provided text, here's the information that can be extracted, with explanations for what is not present:
1. Table of acceptance criteria and the reported device performance
The document does not specify quantitative "acceptance criteria" or "reported device performance" in terms of accuracy metrics (e.g., sensitivity, specificity, precision) typically seen for diagnostic devices. Instead, the substantial equivalence claim focuses on the device's characteristics (intended use, form, matrix, levels, storage, analytes, open vial claim) being similar to a legally marketed predicate device.
| Characteristic | Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (as presented for comparison) |
|---|---|---|
| Intended Use | An unassayed quality control serum for monitoring enzyme immunoassay procedures for the detection of Anti-Jo-1 autoantibodies (matching predicate concept of QA/QC) | An unassayed quality control serum for monitoring enzyme immunoassay procedures for the detection of Jo-1 autoantibodies. |
| Form | Liquid (matching predicate) | Liquid |
| Matrix | Human Serum (matching predicate) | Human Serum |
| Levels | Negative, Positive, Cutoff (for predicate); Expected to provide relevant control levels. | Negative, Positive, High Positive (different from predicate but still provides control levels for the intended purpose) |
| Storage | 2-8°C (matching predicate) | 2-8°C |
| Analytes | Includes Anti-Jo-1 as one of the analytes (predicate covers a broader panel) | Anti-Jo-1 (focused on a specific analyte as a quality control) |
| Open Vial Claim | Shelf life (for predicate) | 30 Days at 2-8°C (a specific, defined claim) |
Explanation: The "acceptance criteria" for a quality control device typically relate to its stability, uniformity, and ability to produce expected results within a specified range when tested with appropriate assays. This document, being a 510(k) summary, primarily focuses on demonstrating that the device is "substantially equivalent" to a predicate device rather than presenting a detailed performance study with quantitative acceptance thresholds for accuracy. The comparison table essentially serves as the "study" for substantial equivalence, showing that the key characteristics align or are appropriately addressed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The 510(k) summary for this quality control device focuses on demonstrating substantial equivalence based on technological characteristics and intended use, rather than clinical performance data from patient samples. Therefore, there is no mention of a "test set" of patient data in the context of typical diagnostic device evaluation.
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)
This information is not applicable and not provided for this type of device (quality control). Ground truth determination by experts is relevant for diagnostic devices that interpret patient results.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided for this type of device (quality control). Adjudication methods are used for resolving discrepancies in expert interpretations of diagnostic data.
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
This information is not applicable and not provided. An MRMC study is relevant for diagnostic imaging or interpretation systems, particularly those that involve human readers and AI assistance. This device is a quality control product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. A standalone performance evaluation is relevant for automated diagnostic algorithms. This device is a biochemical control.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not applicable and not provided. "Ground truth" in the context of diagnostic accuracy is not relevant for a quality control product where the objective is to ensure the consistent performance of an assay. The "ground truth" for a quality control material would generally refer to its known characteristics and stability, which are validated during manufacturing.
8. The sample size for the training set
This information is not provided and is not applicable for this type of device. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for this type of device.
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Laboratories
e, California 92618-2017 phone: (949) 598-12
198000
510(k) Summary
Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA (949)598-1285 Fax (714)598-1555
Contact Person Elizabeth Platt
te of Summary Preparation Jecember 14, 1998
Device (Trade & Common Name) Liquichek Anti-Jo-1 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-Jo-1 Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of Jo-1 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
Liquichek Anti-Jo-1 Control, EIA 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.
Statement of How Technological Characteristics Compare to Substantial Equivalent Device A table is provided below comparing the similarities between the Bio-Rad Liquichek Anti-Jo-1, EIA and the device to which substantial equivalence is claimed.
| Helix Enzyme Immunoassay AntinuclearAntibody Screening Test Kit | Bio-Rad Liquichek Anti-Jo-1Control, 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 Jo-1autoantibodies. |
| 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-Jo-1 |
| Open VialClaim | Shelf life | 30 Days at 2-8°C |
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 22 1998
Ms. Elizabeth Platt Staff Regulatory Affairs Representative BIO-RAD LABORATORIES 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K984464 Trade Name: Liquichek Anti-Jo-1 Control, EIA Model #211 Regulatory Class: II Product Code: LKJ Dated: December 14, 1998 December 16, 1998 Received:
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 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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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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Toutman
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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12984464 510(k) Number:
Device Name: Liquichek Anti-Jo-1 Control, ElA
Indications for Use:
Liquichek Anti-Jo-1 Control, EIA is intended for use as an unassayed quality control to monitor enzyme immunoassay procedures for the detection of Anti-Jo-1 autoantibodies.
(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 | 1984464 |
| Prescription Use | OR | Over-The Counter Use | ||
|---|---|---|---|---|
| ------------------ | ------- | ---- | ---------------------- | ------- |
§ 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).