(23 days)
The Liquichek™ Anti-nDNA Control, Positive is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of nDNA autoantibodies.
This product is prepared from human serum with added preservatives. The control is provided in liquid form for convenience.
This document describes a submission for a medical device called "Liquichek™ Anti-nDNA Control, Positive" to the FDA for market clearance. It is not an AI/ML device, and therefore several of your requested categories are not applicable.
Here's an analysis based on the provided text, focusing on the information that is available and noting where the requested information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Study | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Intended Use | The device's intended use should be met. | The Liquichek™ Anti-nDNA Control, Positive is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of nDNA autoantibodies. This aligns with its classification as an Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control. |
| Open Vial Stability | The analyte should remain stable for a specified period after opening. | Once the control is opened, the analyte will be stable for 60 days when stored tightly capped at 2 to 8°C. |
| Shelf Life (Unopened) | The control should be stable for a specified period when stored unopened. | The control is stable for 2 years when stored unopened at 2-8°C. |
| Comparability to Predicate Device | The new device should be substantially equivalent to the predicate device in terms of intended use, matrix, and storage conditions. | The new device has identical intended use, human serum matrix, and unopened storage conditions (2°C to 8°C until expiration date) compared to the predicate device (Kallestad™ Autoantibody Positive Control, K780899A). Differences exist in opened stability (60 days liquid vs. 6 weeks/4 months reconstituted) and form (liquid vs. lyophilized), and in the specific analytes (Anti-nDNA only for new device vs. a broader panel for predicate). The FDA determined substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as the device is a quality control material and the studies described are stability studies, not performance studies on a clinical test set. The document does not describe "test sets" in the context of diagnostic accuracy. The studies were performed by Bio-Rad Laboratories.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a quality control product, not a diagnostic test that requires expert interpretation of results for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable for the same reasons as above.
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 device is a quality control material, not an AI/ML diagnostic algorithm. Therefore, no MRMC study or AI-related effectiveness was assessed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical reagent, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the stability characteristics of the control material itself. This was established through real-time stability studies conducted by Bio-Rad Laboratories, which are likely laboratory measurements of the control's performance over time under specified storage conditions. The document states "Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Anti-nDNA Control, Positive." and "Real time studies will be ongoing to support the shelf life of this product."
8. The Sample Size for the Training Set
Not applicable. This device is a quality control product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as above. The "ground truth" for the stability studies was established through laboratory testing and measurements.
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Page 1 of 3
K.24225
Summary of Safety and Effectiveness Liquichek™ Anti-nDNA Control, Positive
JAN 1 5 2003
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1555 Fax:
Contact Person
Yvette Lloyd Senior Regulatory Affairs Specialist Telephone: (949) 598-1465
Date of Summary Preparation
December 20, 2002
2.0 Device Identification
Liquichek™ Anti-nDNA Control, Positive Product Trade Name:
Antinuclear Antibody, Indirect Immunofluorescent, Common Name: Antigen, Control
| Classifications: | Class II |
|---|---|
| Product Code: | 82DHN |
| Regulation Number: | 21 CFR 866.5100 |
Device to Which Substantial Equivalence is Claimed 3.0
Kallestad TM Autoantibody Positive Control Bio-Rad Laboratories
510 (k) Number: K780899A
Description of Device 4.0
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 Liquichek™ Anti-nDNA Control, Positive is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of nDNA autoantibodies.
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: K780899A
Table 1. Similarities and Differences between new and predicate device.
| Characteristics | Liquichek™ Anti-nDNA Control,Positive(New Device) | Kallestad™ Autoantibody PositiveControl(Predicate Device) |
|---|---|---|
| Similarities | ||
| Intended Use | The Liquichek™ Anti-nDNAControl, Positive is intended foruse as an unassayed qualitycontrol to monitor indirectimmunofluorescent testing for thedetection of nDNA autoantibodies. | 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 |
| Differences | ||
| Stability(Opened) | Once opened the analyte will bestable for 60 days. | Aliquots of the reconstitutedsolution are stable at 2-8°C for 6weeks and at -20°C for 4 months. |
| Form | Liquid | Lyophilized |
| Analyte | Anti-nDNA | ANA: Centromere Pattern, SSA,SSB, Scl-70, Sm, RNP, SpindlePattern, Nucleolar PatternAMAASMAAPCAAnti-nDNA |
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7.0 Summary of Performance Data
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Anti-nDNA Control, 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 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 U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus symbol.
JAN 1 5 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, California 92618-2017
K024225 Trade/Device Name: Liquichek™ Anti-nDNA Control, Positive Regulation Number: 21 CFR § 866.5100 Regulation Name: Antinuclear Antibody (Indirect)/Immunofluorescent, Antigen, Control Regulatory Class: II Product Code: DHN Dated: December 20, 2002 Received: December 23, 2002
Dear Ms. Lloyd:
Re:
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. Iisting 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.
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Page 2
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). 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 Sutmes
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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KO24225 510 (k) Number (if known):____________________________________________________________________________________________________________________________________________________
Liquichek™ Anti-nDNA Control, Positive Device Name:
Indications for Use:
The Liquichek™ Anti-nDNA Control, Positive is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of nDNA autoantibodies.
(PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF. NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use
Over-the Counter use
J. Reeve for J. Batista
(Division Sign Off)
or
Division of Clinical Laboratory Devices
KOZM225 510(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).