(23 days)
K780899A
Not Found
No
The document describes a quality control material for laboratory testing and does not mention any AI or ML components.
No.
The device is described as an "unassayed quality control to monitor indirect immunofluorescent testing," indicating it is used for diagnostic quality control, not for treating a disease or condition.
No
This device is a quality control material intended to monitor indirect immunofluorescent testing, not to diagnose a condition itself.
No
The device description explicitly states the product is prepared from human serum and is provided in liquid form, indicating it is a physical substance, not software.
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 for the detection of nDNA autoantibodies." This testing is performed in vitro (outside the body) on patient samples (implied by the context of autoantibody testing).
- Device Description: The description mentions it's prepared from "human serum," which is a biological sample used in in vitro diagnostic tests.
- Function: The device acts as a "quality control" for an in vitro diagnostic test. Quality controls are essential components of IVD procedures to ensure the accuracy and reliability of the test results.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Liquichek™ Anti-nDNA Control, Positive is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of nDNA autoantibodies.
Product codes (comma separated list FDA assigned to the subject device)
82DHN
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
Not Found
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™ Anti-nDNA Control, 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.
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.
K780899A
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).
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Page 1 of 3
K.24225
Summary of Safety and Effectiveness Liquichek™ Anti-nDNA Control, Positive
JAN 1 5 2003
1.0 Submitter
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
Liquichek™ Anti-nDNA Control, Positive Product Trade Name:
Antinuclear Antibody, Indirect Immunofluorescent, Common Name: Antigen, Control
| Classifications: | Class II |
|---|---|
| Product Code: | 82DHN |
| Regulation Number: | 21 CFR 866.5100 |
Device to Which Substantial Equivalence is Claimed 3.0
Kallestad TM Autoantibody Positive 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.
1
5.0 Statement of Intended Use
The Liquichek™ Anti-nDNA Control, Positive is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of nDNA 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: K780899A
Table 1. Similarities and Differences between new and predicate device.
| Characteristics | Liquichek™ Anti-nDNA Control,
Positive
(New Device) | Kallestad™ Autoantibody Positive
Control
(Predicate Device) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | The Liquichek™ Anti-nDNA
Control, Positive is intended for
use as an unassayed quality
control to monitor indirect
immunofluorescent testing for the
detection of nDNA autoantibodies. | 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 |
| Differences | | |
| Stability
(Opened) | Once opened the analyte will be
stable for 60 days. | Aliquots of the reconstituted
solution are stable at 2-8°C for 6
weeks and at -20°C for 4 months. |
| Form | Liquid | Lyophilized |
| Analyte | Anti-nDNA | ANA: Centromere Pattern, SSA,
SSB, Scl-70, Sm, RNP, Spindle
Pattern, Nucleolar Pattern
AMA
ASMA
APCA
Anti-nDNA |
2
7.0 Summary of Performance Data
Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Anti-nDNA Control, 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 U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus symbol.
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
K024225 Trade/Device Name: Liquichek™ Anti-nDNA Control, Positive Regulation Number: 21 CFR § 866.5100 Regulation Name: Antinuclear Antibody (Indirect)/Immunofluorescent, Antigen, Control Regulatory 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 Act. The general controls provisions of the Act include requirements for annual registration. Iisting 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.
4
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 (QS) 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 Sutmes
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
KO24225 510 (k) Number (if known):____________________________________________________________________________________________________________________________________________________
Liquichek™ Anti-nDNA Control, Positive Device Name:
Indications for Use:
The Liquichek™ Anti-nDNA Control, Positive is intended for use as an unassayed quality control to monitor indirect immunofluorescent testing for the detection of nDNA autoantibodies.
(PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF. NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use
Over-the Counter use
J. Reeve for J. Batista
(Division Sign Off)
or
Division of Clinical Laboratory Devices
KOZM225 510(k) Number -