(25 days)
The Liquichek™ Autoimmune Negative Control is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the analytes listed in this package insert.
This product is prepared from human serum with added preservatives. The control is provided in liquid form for convenience.
The given document is a 510(k) premarket notification for a quality control device, not a diagnostic device that performs a clinical assessment. Therefore, the questions related to clinical performance, such as sensitivity, specificity, reader studies, and ground truth establishment in a clinical context, are not applicable. The device in question is a control material for laboratory testing.
Here's an analysis based on the provided information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this device are related to its stability as a quality control material.
| Acceptance Criteria (Product Claims) | Reported Device Performance (from Stability Studies) |
|---|---|
| Once opened, the analyte will be stable for 60 days when stored tightly capped at 2 to 8°C. | The stability studies performed support this claim. |
| The control is stable for 2 years when stored unopened at 2 - 8°C. | The stability studies performed support this claim. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not explicitly state a specific "sample size" in terms of a number of patient samples for a test set, as this is a quality control material, not a diagnostic test for patient samples. The "test set" in this context refers to batches of the control material subjected to stability testing. The document states "Stability studies have been performed," providing no specific number of batches or samples used in these studies.
The data provenance is from Bio-Rad Laboratories, located in Irvine, California, USA. The studies would be prospective as they are "Real time studies" designed to establish stability over time.
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 question is not applicable. For a quality control material, "ground truth" typically refers to its known stability characteristics, which are determined through laboratory testing and analytical protocols, not by expert consensus on clinical findings.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies in expert interpretations of patient data. This device is a lab control, and its performance is assessed via analytical stability studies, not clinical interpretation.
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 question is not applicable. MRMC studies are for evaluating diagnostic devices that rely on human interpretation, often with AI assistance, for clinical cases. This device is a quality control material for laboratory instruments/assays.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is a physical control material, not an algorithm or a software-based diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for a quality control material is its chemical and physical stability over time, which is established through rigorous analytical testing under various conditions (e.g., temperature, light exposure) and measured against predefined specifications for the analytes it controls. The document states that "Stability studies have been performed," implying this type of analytical testing.
8. The sample size for the training set
This question is not applicable. The concept of a "training set" applies to machine learning models, which is not relevant for this physical quality control material.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as above.
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Bio-Rad Laboratories
Premarket Notification Section 510(k) for Liquichek™ Autoimmune Negative Control.
Summary of Safety and Effectiveness
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Page 1 of 3
Summary of Safety and Effectiveness Liquichek™ Autoimmune Negative Control
1.0 Submitter
JAN 1 7 2003
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 (949) 598-1200 Telephone: (949) 598-1555 Fax:
Contact Person
Yvette Lloyd Senior Requlatory Affairs Specialist Telephone: (949) 598-1465
Date of Summary Preparation
December 20, 2002
2.0 Device Identification
| Product Trade Name: | Liquichek™ Autoimmune Negative Control |
|---|---|
| --------------------- | ---------------------------------------- |
Antinuclear Antibody, Indirect Immunofluorescent, Common Name: 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 Negative 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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Statement of Intended Use
5.0
The new Liquichek™ Autoimmune Negative Control is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the analytes listed in this package insert.
6.0 Comparison of the new device with the Predicate Device
This control is substantially equivalent to the following quality control material for autoimmune analysis that is currently in the market:
Kallestad™ Autoantibody Negative Control Bio-Rad Laboratories
510 (k) Number: K780899A
Table 1. Similarities and Differences between new and predicate device.
| Characteristics | Liquichek™ AutoimmuneNegative Control | Kallestad™ Autoantibody NegativeControl |
|---|---|---|
| (New Device) | (Predicate Device) | |
| Similarities | ||
| Intended Use | The Liquichek™ AutoimmuneNegative Control is intended foruse as an unassayed qualitycontrol to monitor indirectimmunofluorescent testing for theanalytes listed in this packageinsert. | The Autoantibody Negative Controlis a replacement reagent in theKallestad FluorescentAutoantibody test with mousekidney, mouse stomach/kidney,Hep-2 cell line, or Crithidia luciliaesubstrates. This test is an indirectfluorescent antibody (IFA)procedure for the detection andsemi-quantitation of humanantibodies. |
| Matrix | Human Serum | Human Serum |
| Storage(Unopened) | 2°C to 8°Cuntil expiration date | 2°C to 8°Cuntil expiration date |
| Form | Liquid | Liquid |
| Differences | ||
| Stability(Opened) | Once opened the analyte will bestable for 60 days. | No open vial claims |
| Analyte | Antinuclear antibodies (ANA)Speckled Pattern, Antinuclearantibodies (ANA) CentromerePattern, Antinuclear antibodies(ANA) Homogenous Pattern,Antinuclear antibodies (ANA)Mitotic Spindle Pattern. | No claims |
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7.0 STATEMENT OF SUPPORTING DATA
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Autoimmune Negative Control. 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 Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human figures, one behind the other, forming a symbolic representation of health and human services.
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
JAN 1 7 2003
Re: K024220
Trade/Device Name: Liquichek™ Autoimmune Negative Control Regulation Number: 21 CFR § 866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory 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 (OS) 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.
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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). You may obtain other general information on your responsibilities under the Act 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):_ КОДЧАДО
Device Name: Liquichek™ Autoimmune Negative Control
Indications for Use:
The Liquichek™ Autoimmune Negative Control is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the analytes listed in this package insert
(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
Aflues for L. Bautista
(Division Sign-Off) Division of Clinical Laborat 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).