(23 days)
The new Liquichek™ ANA Control, Centromere 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 describes the Liquichek™ ANA Control, Centromere Pattern, Positive, a quality control device, and its acceptance criteria as demonstrated for substantial equivalence to a predicate device.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
For a quality control material like this, the "acceptance criteria" and "performance" are primarily related to its stability and its ability to consistently produce the intended "positive" result for Centromere pattern ANAs, which makes it suitable for monitoring tests.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Opened Vial Stability (Desired) | Analyte stable for 60 days when stored tightly capped at 2 to 8°C. |
| Shelf Life (Unopened Vial Stability) | Stable for 2 years when stored unopened at 2 to 8°C. |
| Matrix | Human Serum |
| Form | Liquid |
| Analyte | ANA Centromere Pattern |
| Intended Use | Unassayed quality control for monitoring indirect immunofluorescent testing of antinuclear antibodies (ANA). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ ANA Control Centromere Pattern, Positive." and "Real time studies will be ongoing to support the shelf life of this product."
- Sample Size: The exact sample size (number of vials, replicates, etc.) used for these stability studies is not explicitly stated in the provided text.
- Data Provenance: The studies were conducted by Bio-Rad Laboratories, presumably at their facilities. The document doesn't specify if the data is retrospective or prospective, but as it refers to "ongoing" real-time studies, it implies a prospective data collection approach for shelf life confirmation. The country of origin would be the USA, where Bio-Rad Laboratories is based.
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)
Given that this is a quality control material intended for use in an indirect immunofluorescent assay (IFA) for antinuclear antibodies (ANA), the "ground truth" for the device itself would be its characterized performance and stability, rather than interpretations by experts in a diagnostic sense. The document does not mention the use of external experts for establishing the ground truth of the control's characteristics. The internal Bio-Rad scientists and quality control personnel would have characterized the material's properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This type of adjudication method (e.g., 2+1, 3+1) is typically used in studies where human readers interpret medical images or complex diagnostic results, and their interpretations are compared to reach a consensus for ground truth. For a quality control material stability study, it is not applicable and therefore, no such method was employed or described. The performance is assessed through analytical testing results.
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
An MRMC comparative effectiveness study is relevant for diagnostic devices that involve significant human interpretation, especially when evaluating the impact of AI assistance. This device is a quality control material, not an AI-assisted diagnostic tool. Therefore, no MRMC study was performed or is relevant in this context, and there is no mention of AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of an algorithm without human involvement. Since this device is a quality control material and not an algorithm or AI system, no standalone algorithm performance study was done or is applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this quality control material, the "ground truth" for its performance is established through analytical characterization and stability testing against predefined specifications. This includes:
- Demonstrating the presence and appropriate titer of ANA Centromere pattern using established IFA methodologies.
- Measuring its stability over time under specified storage conditions through quantitative and qualitative analytical methods (e.g., retesting activity at various time points).
- Ensuring the matrix (human serum) and preservatives are appropriate and do not interfere with the intended use.
It is based on internal laboratory testing and compliance with quality control standards, rather than external expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set
This device is not an AI/machine learning model, so there is no "training set" in the conventional sense. The "training" or characterization of the control material is part of its manufacturing and quality assurance process, which involves preparing batches of the control and testing them to ensure they meet specifications.
9. How the ground truth for the training set was established
As there is no training set for an AI model, this question is not applicable. The "ground truth" for the control material itself is established through rigorous analytical testing and established manufacturing protocols to ensure it consistently provides the expected Centromere pattern ANA positive signal and maintains stability.
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K024222
Summary of Safety and Effectiveness Liquichek™ ANA Control, Centromere Pattern, Positive
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1555
JAN 1 5 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 Speckled 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
Liquichek™ ANA Control, Centromere Pattern Bio-Rad Laboratories
510 (k) Number: K984397
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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Statement of Intended Use 5.0
The new Liquichek™ ANA Control, Centromere 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:
Liquichek™ ANA Control, Centromere Pattern Bio-Rad Laboratories
510 (k) Number: K984397
Table 1. Similarities and Differences between new and predicate device.
| Characteristics | Liquichek™ ANA Control,Centromere Pattern, Positive(New Device) | Liquichek™ ANA Control,Centromere Pattern(Predicate Device) |
|---|---|---|
| Similarities | ||
| Intended Use | The new Liquichek™ ANAControl, Centromere Pattern,Positive, is intended for use as anunassayed quality control tomonitor indirectimmunofluorescent testing ofantinuclear antibodies (ANA). | The Liquichek™ ANA Control,Centromere Pattern is intended foruse as an unassayed qualitycontrol to monitor indirectimmunofluorescent testing ofantinuclear antibodies (ANA). |
| Matrix | Human Serum | Human Serum |
| Storage(Unopened) | 2°C to 8°Cuntil expiration date | 2°C to 8°Cuntil expiration date |
| Form | Liquid | Liquid |
| Analyte | ANA Centromere Pattern | ANA Centromere Pattern |
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| Differences | ||
|---|---|---|
| Stability(Opened) | Once opened the analyte will be stable for 60 days. | Once opened the analyte will be stable for 30 days. |
7.0 Summary of Performance Data
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ ANA Control Centromere Pattern, Positive. Product claims are as follows:
- Once the control is opened the analyte will be stable for 60 days when 7.1 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 ongoing 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 Department of Health & Human Services (HHS) in the USA. The logo features a stylized image of an eagle with three lines representing its wings and head. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the upper half of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 5 2003
Ms. Yvette Lloyd Senior Regulatory Affairs Specialist Bio-Rad Laboratories, QSD 9500 Jeronimo Road Irvine, CA 92618-2017
Re: K024222
Trade/Device Name: Liquichek™ ANA Control, Centromere 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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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 Butman
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): K024222
Device Name: Liquichek™ ANA Control, Centromere Pattern, Positive
Indications for Use:
The new Liquichek™ ANA Control, Centromere 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 V or
Over-the Counter use
J.P. Reeves for J. Bautista
Division Sign Off
Division of Clinical Laboratory Devices
10(k) Number_(c 0 2 צלי ר' 10)10
§ 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).