(23 days)
The new Liquichek™ Anti-Smooth Muscle Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of smooth muscle autoantibodies.
This product is prepared from human serum with added preservatives. The control is provided in liquid form for convenience.
This is a 510(k) premarket notification for a quality control device, not a diagnostic or AI-powered device. Therefore, the typical acceptance criteria and study design elements you've requested for such devices (e.g., sample size for test/training set, expert ground truth, MRMC study, standalone performance) are not applicable or provided in this document.
The document describes the submission of a "Liquichek™ Anti-Smooth Muscle Control, Positive" to the FDA, claiming substantial equivalence to a predicate device, the "Kallestad™ Autoantibody Positive Control." The purpose of this device is to serve as an unassayed quality control for indirect immunofluorescent testing to detect smooth muscle autoantibodies.
Here's an attempt to address your points based on the provided document, noting the limitations due to the nature of the device:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of quality control device, "acceptance criteria" and "device performance" are typically related to its ability to consistently produce expected results when used in the intended assay, demonstrating its suitability as a control. However, this document does not explicitly state specific acceptance criteria or quantitative performance data beyond the claim of substantial equivalence. The "performance" is primarily implied by its similarity to the predicate device and its intended use as a quality control.
| Characteristic | Acceptance Criteria (Implied/General for QC) | Reported Device Performance (Implied by Substantial Equivalence and Intended Use) |
|---|---|---|
| Intended Use | To effectively monitor indirect immunofluorescent testing for smooth muscle autoantibodies. | The new device is intended for the same purpose as the predicate, to monitor indirect immunofluorescent testing for smooth muscle autoantibodies. |
| Matrix | Formulated in a human serum matrix. | Prepared from human serum. |
| Storage | Stable at specified storage conditions (2°C to 8°C) until expiration. | Stable at 2°C to 8°C until expiration date. |
| Form | Provided in a liquid, ready-to-use format. | Provided in liquid form. |
| Equivalence | Demonstrated substantial equivalence to a legally marketed predicate device (Kallestad™ Autoantibody Positive Control). | Through comparison (Table 1), the new device shares key characteristics (intended use, matrix, storage, form) with the predicate device, leading to an FDA finding of substantial equivalence (K024224). |
2. Sample Size for the Test Set and Data Provenance
This document describes a 510(k) submission for a quality control material. It does not involve a "test set" in the sense of patient data for diagnostic classification. The "comparison" is between the new control fluid and an existing predicate control fluid. The document does not specify a "sample size" in relation to a patient test set, nor does it refer to data provenance (country of origin, retrospective/prospective) because it's not evaluating the performance of a diagnostic algorithm or predictive model on patient samples.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable for this type of submission. There is no "ground truth" to be established by experts in the context of diagnostic accuracy for this quality control device. The FDA's review process relies on regulatory experts assessing the substantial equivalence claim based on the provided data comparing the new device to the predicate.
4. Adjudication Method
Not applicable. No adjudication method is described as there is no diagnostic outcome being evaluated for human readers or algorithms.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic device involving human readers or AI assistance in interpretation. Therefore, an MRMC study and effect size for human improvement are not relevant.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop)
Not applicable. This device is a quality control material, not an algorithm. Its "performance" is about its stability and consistency as a control for an assay, not a standalone diagnostic interpretation by an algorithm.
7. Type of Ground Truth Used
Not applicable. The concept of "ground truth" (expert consensus, pathology, outcomes data) is typically used for evaluating diagnostic devices or algorithms against a definitive reference standard. This document concerns a quality control product, not a diagnostic test seeking to establish a specific medical condition.
8. Sample Size for the Training Set
Not applicable. This is a quality control material, not an AI/algorithm-driven device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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Summarv of Safety and Effectiveness Liquichek™ Anti-Smooth Muscle Control, Positive
1.0 Submitter
JAN 1 5 2003
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
| Product Trade Name: | Liquichek™ ANA Control Speckled Pattern, Positive |
|---|---|
| Common Name: | Antinuclear Antibody, Indirect Immunofluorescent,Antigen, Control |
| Classifications: | Class II |
| Product Code: | 82DBE |
| 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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Statement of Intended Use 5.0
The new Liquichek™ Anti-Smooth Muscle Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of smooth muscle 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: K792610
Table 1. Similarities and Differences between new and predicate device.
| Characteristics | Liquichek™ Anti-Smooth MuscleControl, Positive(New Device) | Kallestad™ Autoantibody PositiveControl(Predicate Device) |
|---|---|---|
| Similarities | ||
| Intended Use | The Liquichek™ Anti-SmoothMuscle Control, Positive, isintended for use as an unassayedquality control to monitor indirectimmunofluorescent testing for thedetection of smooth muscleautoantibodies. | 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
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
Re: K024224
Trade/Device Name: LiquichekTM Anti-Smooth Muscle Control, Positive Regulation Number: 21 CFR § 866.5120 Regulation Name: Anti-Smooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control Regulatory Class: II Product Code: DBE 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.
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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 (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.
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 Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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K024224 510 (k) Number (if known):
Liquichek™ Anti-Smooth Muscle Control, Positive Device Name:
Indications for Use:
The new Liquichek™ Anti-Smooth Muscle Control, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of smooth muscle autoantibodies.
(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
I. Pleeves for J. Bantista
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K024224
§ 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).