(197 days)
Not Found
Not Found
No
The document describes a quality control material for urinalysis and does not mention any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device is described as an assayed quality control material for urinalysis, which is used to evaluate test procedures, not to treat a condition or disease.
No
Explanation: The device is described as a quality control material intended to evaluate reagent strips, hCG methods, confirmatory tests, and microscopic examination procedures. Its purpose is to ensure the accuracy of diagnostic tests, not to diagnose a condition itself.
No
The provided text describes a liquid quality control material for urinalysis, which is a physical substance, not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is a "quality control material for various urinalysis reagent strips, qualitative hCG methods as well as confirmatory tests... and to evaluate microscopic examination test procedures." These are all tests performed in vitro (outside the body) on biological samples (urine).
- Quality Control Material: Quality control materials are a key component of IVD testing, used to ensure the accuracy and reliability of the diagnostic tests themselves.
Therefore, the CLINIQA® Liquid QC™ DipScopics Urinalysis Control fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CLINIQA® Liquid QC™ DipScopics Urinalysis Control is intended for use as an assayed quality control material for various urinalysis reagent strips, qualitative hCG methods as well as confirmatory tests such as Acetest®, Clinitest", and Ictotest This control is also intended to evaluate microscopic examination test procedures
Product codes
JJW
Device Description
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol, with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
CLINIQA Corporation c/o Ms Dawn Gast Quality Manager 288 Dıstrıbutıon Street San Marcos, CA 92078
JAN 1 6 2009
Re K081908
CLINIQA Liquid QC Urinalysis Controls, Levels 1 and 2 Trade Name Regulation Number 21 CFR 862 1660 Regulation Name Quality Control Material (Assayed and Unassayed) Regulatory Class Class I (Reserved) Product Codes JJW Dated September 03, 2008 Received October 29, 2008
Dear Ms Gast
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 undications 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, Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteratıon
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 (OS) regulation (21 CFR Part 820)
1
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) You may obtain other general information on your responsibilities under the Act 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/dsmamaın html
Sincerely yours,
Corg C. He
Courtney C Harper, Ph D Acting Director DIvision of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
2
Indication for Use
510(k) Number (if known) K081908
Device Name CLINIQA® Liquid QCTM Urinalysis Controls, Levels 1 and 2
Indication For Use
CLINIQA® Liquid QC™ DipScopics Urinalysis Control is intended for use as an assayed quality control material for various urinalysis reagent strips, qualitative hCG methods as well as confirmatory tests such as Acetest®, Clinitest", and Ictotest This control is also intended to evaluate microscopic examination test procedures
Prescription Use x (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE, CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benom
Division Sign Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081908
Page 1 of 1