(21 days)
The Liquichek™ ANA Control, Mitotic Spindle Pattern, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).
This product is prepared from human serum with added preservatives. The control is provided in liquid form for convenience.
This document is a 510(k) Premarket Notification for a Liquichek™ ANA Control, Mitotic Spindle Pattern, Positive. It is a regulatory submission to the FDA demonstrating substantial equivalence to a predicate device, not a study performing clinical validation of a diagnostic algorithm or AI device. Therefore, much of the requested information (like expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, etc.) is not applicable to this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for a control device like this are primarily related to its stability, which ensures it functions reliably as a quality control material over time. The document doesn't provide specific quantitative performance metrics like sensitivity or specificity because it's a control, not a diagnostic test. Instead, its performance is described in terms of its stability.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Open vial stability | 60 days when stored tightly capped at 2-8°C |
| Unopened shelf life | 2 years when stored unopened at 2-8°C |
| Equivalence to predicate device for stated intended use | Found substantially equivalent by FDA (K024231) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: Not explicitly stated. The stability studies would involve multiple units of the control material tested over time, but the exact number isn't provided.
- Data Provenance: The document states, "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." This indicates the studies were likely conducted internally by Bio-Rad Laboratories, presumably in a laboratory setting. The data is prospective for stability testing, as it tracks the product over its claimed shelf life. There is no information about country of origin beyond "Bio-Rad Laboratories 9500 Jeronimo Road, Irvine. California".
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a quality control material. Its "ground truth" is its inherent characteristic (e.g., the presence of ANA Mitotic Spindle Pattern) which is established during its manufacturing and characterization, not by human experts interpreting clinical data.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the sense of patient samples requiring expert adjudication. The performance data relates to the stability of the control material itself.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a quality control device, not a diagnostic algorithm that would be used by human readers to interpret cases. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a laboratory control material, not an algorithm.
7. The Type of Ground Truth Used
For the characterization of the control material, the ground truth is its known composition and reactivity (presence of ANA Mitotic Spindle Pattern). This is established through the manufacturing process and internal quality assurance testing to ensure it consistently provides the expected reactive pattern. It is not based on expert consensus, pathology, or outcomes data in a clinical trial sense.
8. The Sample Size for the Training Set
Not applicable. As this is a control material, there is no "training set" in the context of machine learning or algorithm development. The manufacturing process and quality control methods are developed and refined over time based on internal laboratory practices and standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See point 8).
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Image /page/0/Picture/2 description: The image contains a sequence of alphanumeric characters that appear to be handwritten. The characters are 'KO24231'. The writing style is casual, and the characters are connected, giving it a cursive appearance. The image is simple and focuses solely on the written characters.
Summary of Safety and Effectiveness Liquichek™ ANA Control Mitotic Spindle Pattern, Positive
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine. California 92618-2017 Telephone: (949) 598-1200 (949) 598-1555 Fax:
JAN 1 3 2003
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 Mitotic Spindle 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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5.0 Statement of Intended Use
The new Liquichek™ ANA Control, Mitotic Spindle 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, MitoticSpindle Pattern, Positive(New Device) | Kallestad™ Autoantibody PositiveControl(Predicate Device) |
|---|---|---|
| Similarities | ||
| Intended Use | The new Liquichek™ ANAControl, Mitotic Spindle Pattern,Positive, is intended for use as anunassayed quality control tomonitor 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 Mitotic Spindle Pattern | ANA: Centromere Pattern, SSA,SSB, Scl-70, Sm, RNP, SpindlePattern, 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 Liguichek™ ANA Control, Mitotic Spindle 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 onqoing 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 U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles three abstract human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.
JAN 1 3 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Yvette Lloyd Senior Regulatory Affairs Specialist Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K024231
Trade/Device Name: Liquichek™ ANA Control. Mitotic Spindle 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:
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 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 (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,
Steven 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):____________________________________________________________________________________________________________________________________________________
Device Name:
Liquichek™ ANA Control, Mitotic Spindle Pattern, Posítive
Indications for Use:
The Liquichek™ ANA Control, Mitotic Spindle 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)
| Prescription use | ✓ | or | Over-the Counter use | |
|---|---|---|---|---|
| ------------------ | --------------------------------------------------- | ---- | ---------------------- | -------------------------------------------------- |
HReeves for J. Bautista
(Division Sign-Off)
Division of Clinical Laboratory Devices510(k) Number .
§ 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).