(23 days)
The Liquichek ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns, is intended for use as an unassayed quality control set to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).
These products are prepared from human serum with added preservatives. These controls are provided in liquid form for convenience
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text, while noting the limitations in the given information for some of your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Opened Vial Stability | Analytes stable for 60 days when stored tightly capped at 2 to 8°C. | "Once the controls are opened the analytes will be stable for 60 days when stored tightly capped at 2 to 8°C." (Claim made based on stability studies) |
| Unopened Vial Stability (Shelf Life) | Analytes stable for 2 years when stored unopened at 2-8°C. | "The control is stable for 2 years when stored unopened at 2-8ºC." (Claim made based on stability studies) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the stability studies or any "test set" in the context of diagnostic accuracy. The study is described as "Stability studies," which are typically laboratory-based assessments of product degradation over time. Data provenance (country of origin, retrospective/prospective) is also not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The "ground truth" here would be the actual stability of the control analytes over time. This is typically determined by analytical methods, not expert consensus in the same way clinical diagnostic accuracy is.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in diagnostic studies involving human interpretation. Here, the "study" is a stability assessment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for evaluating the impact of AI on human readers in diagnostic tasks, which is not the purpose of this device (a quality control set).
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
No, a standalone performance study was not done. This device is a quality control material, not an algorithm. Its performance is related to its stability and ability to elicit the expected immunofluorescent patterns, not an independent algorithm's diagnostic accuracy.
7. The Type of Ground Truth Used
The "ground truth" for the stability studies would be the analytical measurements of the concentration or reactivity of the ANA patterns in the controls over time. This is determined through established laboratory methods, comparing the results over the noted timeframes to initial values or reference standards. The document states "All supporting data is retained on file at Bio-Rad Laboratories," implying internal analytical testing.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The device is a manufactured control material, not an AI algorithm requiring a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided as there is no "training set" for this type of device.
Overall Study Summary:
The device, Liquichek™ ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns, underwent stability studies to determine its shelf life and open-vial stability. These studies supported the claims that:
- Once opened, the analytes in the controls are stable for 60 days when stored tightly capped at 2 to 8°C.
- The control is stable for 2 years when stored unopened at 2-8°C.
The document indicates these are "Product claims" based on the performed stability studies, with "All supporting data... retained on file at Bio-Rad Laboratories." The specifics of the methodology, including the number of batches tested, the frequency of testing, and the exact analytical methods used to verify stability, are not detailed in this summary. The purpose of this submission (K024230) was to demonstrate substantial equivalence to previously cleared predicate devices for the intended use as an unassayed quality control set for indirect immunofluorescent testing of antinuclear antibodies.
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Summary of Safety and Effectiveness
Liquichek™ ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns
1.0 Submitter
JAN 1 5 2003
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 (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 Controls Set, Positive:Homogeneous, Speckled, Centromere, and NucleolarPatterns |
|---|---|
| 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
-
. Kallestad™ ANA Positive Control Homogeneous Pattern Bio-Rad Laboratories
510 (k) Number: K792610 -
川. Liquichek™ ANA Control, Centromere Pattern Bio-Rad Laboratories
510 (k) Number: K984397
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III. Kallestad ™ Autoantibody Positive Control Bio-Rad Laboratories
510 (k) Number: K792610
4.0 Description of Device
These products are prepared from human serum with added preservatives. These controls are provided in liquid form for convenience
5.0 Statement of Intended Use
The new Liquichek™ ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns, is intended for use as an unassayed quality control set to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).
6.0 Comparison of the new device with the Predicate Device
The controls in the set are substantially equivalent to the following quality control materials for autoimmune analyses that is currently in the market:
-
Kallestad ™ ANA Positive Control Homogeneous Pattern ﺎ . Bio-Rad Laboratories
510 (k) Number: K792610 -
II. Liquichek™ ANA Control, Centromere Pattern Bio-Rad Laboratories
510 (k) Number: K984397 -
III. Kallestad TM Autoantibody Positive Control Bio-Rad Laboratories
510 (k) Number: K792610
Tables 1-3 (below) contains comparison information of similarities and differences between the new Liquichek ™ ANA Controls Set, Positive: Homogeneous. Speckled, Centromere, and Nucleolar Patterns and the currently Kallestad™ ANA Positive Control Homogeneous Pattern, Liquichek™ ANA Control. Centromere Pattern, and Kallestad™ Autoantibody Positive Control to which substantial equivalence is claimed.
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Table 1. Similarities and Differences between new and predicate device
Liquichek™ ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns and Kallestad™ ANA Positive Control Homogeneous Pattern
| Characteristics | Liquichek™ ANA Controls Set,Positive: Homogeneous,Speckled, Centromere, andNucleolar Patterns(New Device) | Kallestad™ ANA Positive ControlHomogeneous Pattern(Predicate Device) |
|---|---|---|
| Similarities | ||
| Intended Use | The Liquichek ANA Controls Set,Positive: Homogeneous,Speckled, Centromere, andNucleolar Patterns, is intended foruse as an unassayed qualitycontrol set to monitor indirectimmunofluorescent testing ofantinuclear antibodies (ANA). | The intended use of the ANAPositive Control HomogeneousPattern is the quality control ofindirect fluorescent antibodyprocedures for the detection andsemi-quantitation of humanautoantibodies to nuclear antigens(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 |
| Differences | ||
| Stability(Opened) | Once opened the analytes will bestable for 60 days. | No claim for stability |
| Packaging | 1 vial of each single analytecontrol | Single analyte control |
| Analyte | ANA Homogeneous PatternANA Centromere PatternANA Speckled PatternANA Nucleolar Pattern | ANA Homogeneous Pattern |
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Page 4 of 6
Table 2. Similarities and Differences between new and predicate device
Liquichek™ ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns and Liquichek™ ANA Control, Centromere Pattern
| Characteristics | Liquichek™ ANA Controls Set,Positive: Homogeneous,Speckled, Centromere, andNucleolar Patterns(New Device) | Liquichek™ ANA Control,Centromere Pattern(Predicate Device) |
|---|---|---|
| Similarities | ||
| Intended Use | The Liquichek ANA Controls Set,Positive: Homogeneous,Speckled, Centromere, andNucleolar Patterns, is intended foruse as an unassayed qualitycontrol set to monitor 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 |
| Differences | ||
| Stability(Opened) | Once opened the analytes will bestable for 60 days. | Once opened the analyte will bestable for 30 days. |
| Packaging | 1 vial of each single analytecontrol | Single analyte control |
| Analyte | ANA Homogeneous PatternANA Centromere PatternANA Speckled PatternANA Nucleolar Pattern | ANA Centromere Pattern |
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Table 3. Similarities and Differences between new and predicate device
Liquichek™ ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns and Kallestad™ Autoantibody Positive Control
| Characteristics | Liquichek™ ANA Controls Set,Positive: Homogeneous,Speckled, Centromere, andNucleolar Patterns(New Device) | Kallestad™ Autoantibody PositiveControl(Predicate Device) |
|---|---|---|
| Similarities | ||
| Intended Use | The Liquichek ANA Controls Set,Positive: Homogeneous,Speckled, Centromere, andNucleolar Patterns, is intended foruse as an unassayed qualitycontrol set to monitor indirectimmunofluorescent testing ofantinuclear antibodies (ANA). | 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 |
| Differences | ||
| Stability(Opened) | Once opened the analytes will bestable for 60 days. | No claim for stability |
| Packaging | 1 vial of each single analytecontrol | Single analyte control |
| Analyte | ANA Homogeneous PatternANA Centromere PatternANA Speckled PatternANA Nucleolar Pattern | 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™ ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns. Product claims are as follows:
- 7.1 Once the controls are opened the analytes 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 8ºC.
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/6/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a bird in flight, with three curved lines representing the bird's body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird image.
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
K024230 Re:
Trade/Device Name: Liguichek110 ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns 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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Page 2 -
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.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):____________________________________________________________________________________________________________________________________________________
Device Name: Liquichek ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns
Indications for Use:
The Liquichek ANA Controls Set, Positive: Homogeneous, Speckled, Centromere, and Nucleolar Patterns, is intended for use as an unassayed quality control set 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 or
Over-the Counter use
AP Reeves for J. Bautista
Clinical Labora
§ 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).