(9 days)
Liquichek ANA Control, Nucleolar Pattern is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).
Liquichek ANA Control, Nucleolar Pattern is prepared from human serum with added preservatives and stabilizers. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.
This document describes the Bio-Rad Liquichek ANA Control, Nucleolar Pattern, a quality control serum for monitoring indirect immunofluorescent testing of antinuclear antibodies (ANA). The submission K984399 is a 510(k) premarket notification claiming substantial equivalence to the Kallestad Quantafluor Autoantibody Positive Control.
Based on the provided text, a detailed study proving the device meets specific acceptance criteria is not present. The document primarily focuses on establishing substantial equivalence to a predicate device and describing the device itself. Therefore, many of the requested sections regarding acceptance criteria and study details cannot be fully answered.
However, based on the information provided, here's what can be inferred and stated:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for a Quality Control Device:
For a quality control (QC) product like the Liquichek ANA Control, Nucleolar Pattern, acceptance criteria typically revolve around its stability, consistency, and its ability to produce expected results (e.g., positive or negative for a specific analyte/pattern) when tested with appropriate assays. Since this is an "unassayed" control, the specific expected values are not provided by the manufacturer but are determined by each laboratory.
Given the nature of the submission (510(k) for a QC device), the "acceptance criteria" presented are implicitly related to demonstrating that the new device performs similarly in its role as a control to the predicate device. The performance is then in terms of how it functions as a control.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Function as an unassayed quality control for monitoring indirect immunofluorescent testing of antinuclear antibodies (ANA). | The Liquichek ANA Control, Nucleolar Pattern is stated to be "intended for use as an unassayed quality control serum for monitoring indirect immunofluorescent testing of antinuclear antibodies (ANA)." This is directly comparable to the predicate device's intended use as an "Autoantibody positive control" for similar tests. |
| Matrix Type: Human Serum. | The device is "prepared from human serum." Its matrix is "Human Serum," identical to the predicate. |
| Analyte Inclusion: Contains ANA (Nucleolar Pattern). | The device specifically includes "ANA (Nucleolar Pattern)," which is one of the patterns mentioned for the predicate device ("ANA (Centromere, SSA, SSB, Scl-70, Sm, RNP, Spindle, Nucleolar)"). |
| Storage Stability: Maintain performance over specified storage conditions and open-vial claims. | Storage: 2-8°C (Same as predicate). Open Vial Claim: 30 Days at 2-8°C (Different from predicate, which has 6 weeks at 2-8°C and 4 months at -20°C). This difference implies testing was done to support the 30-day claim. |
| Form/Levels: (Less direct acceptance criteria for performance, more for characteristics or enhancements) | Form: Liquid (Different from predicate's lyophilized form, described as a "convenience" feature). Levels: Negative, Positive, High Positive (Different from predicate's "Positive" level, indicating broader utility). |
| Preservatives: Use of appropriate preservatives. | Contains "0.1% sodium azide as a preservative." (Not explicitly mentioned for the predicate, but common for such products). |
Note: The provided text does not contain raw performance data or a specific study protocol with defined pass/fail criteria for demonstrating equivalence in terms of analytical performance (e.g., specific titers, linearity, or reproducibility across different ANA assays) for the Liquichek ANA Control, Nucleolar Pattern. Instead, the substantial equivalence relies on comparing its characteristics and intended use to a legally marketed predicate device.
2. Sample Size Used for the Test Set and the Data Provenance
No specific test set or associated sample size is mentioned for a formal performance study in the provided text. The submission focuses on demonstrating substantial equivalence through a comparison of technological characteristics. If any internal validation studies were performed (e.g., for stability or matrix characteristics), the details are not included in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The document does not describe a clinical performance study involving a test set that required expert ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study is not mentioned in the provided text. This type of study is typically associated with diagnostic devices that require human interpretation of images or results, where AI assistance might improve reader performance. As the device is a quality control material, such a study would not be relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
Not applicable. The device is a quality control material, not an algorithm or an AI-based system. Therefore, a standalone performance study in the context of an algorithm's performance is not relevant or described.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the conventional sense of a diagnostic device. For a quality control product, "ground truth" would relate to its known composition and expected behavior (e.g., a known positive control should consistently yield a positive result for the target analyte when tested correctly). The text doesn't describe how this "ground truth" was rigorously established for a testing set, but rather states its intended function as a control with an ANA nucleolar pattern.
8. The Sample Size for the Training Set
Not applicable. The device is a quality control material, not an AI or machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no training set for this type of device.
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Bio-Rad Laboratories
Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
Description of the Device
Liquichek ANA Control, Nucleolar Pattern is prepared from human serum with added preservatives and stabilizers. This product is provided in liquid form for convenience. This product contains 0.1% sodium azide as a preservative.
Statement of How Technological Characteristics Compare to Substantial Equivalent Device
A table is provided below comparing the similarities between the Bio-Rad Liquichek ANA Control, Nucleolar Pattern and the device to which substantial equivalence is claimed.
| Kallestad Quantafluor Autoantibody PositiveControl | Bio-Rad LiquichekANA Control, Nucleolar Pattern | |
|---|---|---|
| Intended Use | Autoantibody positive control for KallestadQuantafluor Fluorescent Autoantobody Testwith mouse kidney, mouse stomach/kidney,Hep-2 cell line, or Crithidia luciliae substrates. | An unassayed quality controlserum for monitoring indirectimmunofluorescent testing ofantinuclear antibodies (ANA). |
| Form | Lyophilized | Liquid |
| Matrix | Human Serum | Human Serum |
| Levels | Positive | Negative, Positive, HighPositive |
| Storage | 2-8°C | 2-8°C |
| Analytes | ANA (Centromere, SSA, SSB, Scl-70, Sm,RNP, Spindle, Nucleolar)AMAASMAAPCAAnti-nDNA | ANA (Nucleolar Pattern) |
| Open VialClaim | 6 weeks at 2-8°C4 months at -20°C | 30 Days at 2-8°C |
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Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvine, California 92618-2017 Telephone: (949) 598-1200
510(k) Summary
Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA (949)598-1285 Fax (949)598-1555
Contact Person Elizabeth Platt
Date of Summary Preparation December 8, 1998
Device (Trade & Common Name) Liquichek ANA Control, Nucleolar Pattern
Classification Name Class II, 82DHN CFR 866.5100: Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control.
Devices to Which Substantial Equivalence is Claimed Kallestad Quantafluor Autoantibody Positive Control Sanofi Diagnostics Pasteur Chaska, Minnesota K813592
Statement of Intended Use
Liquichek ANA Control, Nucleolar Pattern is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).
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DEC 1 8 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Elizabeth Platt Regulatory Affairs Supervisor Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA 92618
Re: K984399
Trade Name: Liquichek ANA Control, Nucleolar Pattern, Model 204 Regulatory Class: II Product Code: DHN Dated: December 8, 1998 Received: December 9, 1998
Dear Ms. Platt:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours.
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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R 964 399 510(k) Number: Device Name: Liquichek ANA Control, Nucleolar Pattern
Indications for Use:
Liquichek ANA Control, Nucleolar Pattern 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-CONTINUE ON ANOTHER PAGE IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation)
|--|--|
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K984399 |
| Prescription Use | OR Over-The Counter Use | ||
|---|---|---|---|
| ------------------ | --------------------------------------------------------------------------- | ------------------------- | -- |
§ 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).