(23 days)
Not Found
No
The summary describes a quality control material for laboratory testing, not a device that processes data or images using AI/ML.
No.
This device is an unassayed quality control used to monitor testing and does not directly treat or diagnose a disease.
No
This device is described as an "unassayed quality control" to monitor testing, not to directly diagnose a patient's condition. While it supports diagnostic procedures, it is not a diagnostic device itself.
No
The device is a liquid control material, not a software application. It is a physical product used to monitor laboratory tests.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring indirect immunofluorescent testing of antinuclear antibodies (ANA)". This type of testing is performed in vitro (outside the body) on patient samples (serum in this case) to diagnose or monitor a medical condition.
- Device Description: The product is prepared from human serum, which is a biological sample used in laboratory testing.
- Quality Control: The device is intended as a quality control, which is a standard component of IVD testing to ensure the accuracy and reliability of the test results.
Therefore, based on the provided information, the Liquichek™ ANA Control, Nucleolar Pattern, Positive, fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The new Liquichek™ ANA Control, Nucleolar Pattern, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).
Product codes (comma separated list FDA assigned to the subject device)
82DHN, DHN
Device Description
This product is prepared from human serum with added preservatives. The control is provided in liquid form for convenience.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ ANA Control, Nucleolar Pattern, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
KO24229
Summary of Safety and Effectiveness Liquichek™ ANA Control Nucleolar Pattern, Positive
1.0 Submitter
JAN 1 5 2003
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1555
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 Nucleolar Pattern, Positive |
|---|---|
| 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™ 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.
1
Statement of Intended Use 5.0
The new Liquichek™ ANA Control, Nucleolar Pattern, Positive, is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing of antinuclear antibodies (ANA).
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™ ANA Control,
Nucleolar Pattern, Positive
(New Device) | Kallestad™ Autoantibody Positive
Control
(Predicate Device) |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | The Liquichek™ ANA Control,
Nucleolar Pattern, Positive, is
intended for use as an unassayed
quality control to monitor indirect
immunofluorescent testing of
antinuclear antibodies (ANA). | The Autoantibody Positive Control
is a replacement reagent in the
Kallestad Fluorescent
Autoantibody test with mouse
kidney, mouse stomach/kidney,
Hep-2 cell line, or Crithidia luciliae
substrates. |
| Matrix | Human Serum | Human Serum |
| Storage
(Unopened) | 2°C to 8°C
until expiration date | 2°C to 8°C
until expiration date |
| Form | Liquid | Liquid |
2
| Differences | ||
|---|---|---|
| Stability | ||
| (Opened) | Once opened the analyte will be stable for 60 days. | No claim for stability |
| Analyte | ANA Nucleolar Pattern | ANA: Centromere Pattern, SSA, SSB, Scl-70, Sm, RNP, Spindle Pattern, Nucleolar Pattern |
| AMA | ||
| ASMA | ||
| APCA | ||
| Anti-nDNA |
7.0 Summary of Performance Data
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ ANA Control, Nucleolar Pattern, 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.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of a human figure with three lines extending from the head.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 5 2003
Ms. Yvette Lloyd Senior Regulatory Affairs Specialist Bio-Rad Laboratories, OSD 9500 Jeronimo Road Irvine, CA 92618-2017
K024229 Trade/Device Name: Liquichek 114 ANA Control. Nucleolar Pattern, Positive 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:
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 A.ct. 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,
iteven 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
5
510 (k) Number (if known): K034229
Device Name: Liquichek™ ANA Control, Nucleolar Pattern, Positive
Indications for Use:
The Liquichek™ ANA Control, Nucleolar Pattern, Positive, 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-CONINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription use or
Over-the Counter use
A. Reeves for J. Bautista
(Division Sign-Off) Division of Clinical Labora 510(k) Number -