(9 days)
Liquichek Anti-dsDNA Control is intended for use as an unassayed quality control to monitor immunoassay procedures for the detection of dsDNA autoantibodies.
Liquichek Anti-dsDNS Control 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.
This looks like a 510(k) submission for an in vitro diagnostic device, specifically a quality control product. The information provided heavily focuses on establishing substantial equivalence to a predicate device, rather than presenting a study demonstrating the device's own performance against acceptance criteria in the way a clinical diagnostic or AI-powered device would.
Therefore, many of the requested categories (like sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for training) are not applicable in the context of this specific regulatory document. The "device performance" in this context refers to its characteristics compared to the predicate, not clinical accuracy or efficacy.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in the typical sense of performance metrics for an AI or clinical diagnostic device. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to an existing legally marketed device (the predicate). The "performance" reported is a comparison of technological characteristics.
| Characteristic | Acceptance Criterion (Similarity to Predicate) | Bio-Rad Liquichek Anti-dsDNA Control Performance |
|---|---|---|
| Intended Use | To monitor immunoassay procedures for detection of dsDNA autoantibodies. | An unassayed quality control serum for monitoring immunoassay procedures for the detection of dsDNA autoantibodies. (Similar to predicate's use for "Anti-nDNA") |
| Form | Lyophilized (Predicate) | Liquid |
| Matrix | Human Serum | Human Serum |
| Levels | Positive (Predicate) | Negative, Positive, High Positive |
| Storage | 2-8°C | 2-8°C |
| Analytes | Anti-nDNA (Predicate) | Anti-dsDNA |
| Open Vial Claim | 6 weeks at 2-8°C / 4 months at -20°C (Predicate) | 30 Days at 2-8°C |
Note: While Form, Levels, Analytes, and Open Vial Claim show differences, the overall argument for substantial equivalence is made, likely by emphasizing the core "monitoring immunoassay procedures for dsDNA/nDNA autoantibodies" with a human serum matrix and similar storage conditions. The specific differences are acknowledged but not deemed to preclude equivalence for its intended use as a control.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This is not a study testing the diagnostic accuracy or performance on patient samples. It's a characterization of a quality control product.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No. This type of study is for evaluating the impact of a diagnostic aid (like AI) on human reader performance, which is not relevant for a quality control product.
- Effect Size: Not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Study: No. This device is a quality control material, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the context of diagnostic accuracy. For a quality control material, the "ground truth" would be the assayed values of the analytes within the control, which are then used to monitor other assays. However, this document describes it as an "unassayed quality control," meaning its exact values are not provided by the manufacturer but determined by the user's specific assay. The primary "ground truth" for this 510(k) is the established characteristics of the predicate device.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. There is no training set for a quality control product.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment: Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo for Bio-Rad. The logo is 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
DEC 18 1998
Description of the Device .
Liquichek Anti-dsDNS Control 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-dsDNA Control and the device to which substantial equivalence is claimed.
| Kallestad Quantafluor Autoantibody PositiveControl | Bio-Rad LiquichekANA Control, HomogeneousPattern | |
|---|---|---|
| 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 monitoringimmunoassay procedures forthe detection of dsDNAautoantibodies. |
| 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 | Anti-dsDNA |
| Open VialClaim | 6 weeks at 2-8°C4 months at -20°C | 30 Days at 2-8°C |
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Image /page/1/Picture/0 description: The image shows the logo for Bio-Rad Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo is in black and white, with the words "BIO-RAD" in bold, sans-serif letters. The logo is simple and recognizable. The logo is encased in a rounded rectangle.
Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 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 Anti-dsDNA Control
Classification Name Class 11, 82LRM CFR 866.5100: Anti-DNA Antibody, Antigen, Control.
Devices to Which Substantial Equivalence is Claimed Kallestad Quantafluor Autoantibody Positive Control Sanofi Diagnostics Pasteur Chaska, Minnesota
Statement of Intended Use
Liquichek Anti-dsDNA Control is intended for use as an unassayed quality control to monitor immunoassay procedures for the detection of dsDNA autoantibodies.
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Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing segments, symbolizing service to the people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEC 18 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA 92618
Re: K984396
Trade Name: Liquichek Anti-dsDNA Control, Model 213 Regulatory Class: II Product Code: LRM 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 Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 vours.
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: K984396
Device Name: Liquichek Anti-dsDNA Control
Indications for Use:
Liquichek Anti-dsDNA Control is intended for use as an unassayed quality control to monitor immunoassay procedures for the detection of dsDNA 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 | K984396 |
|---|---|
| --------------- | --------- |
| 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).