(33 days)
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No
The summary describes quality control materials and calibration verifiers for laboratory systems, with no mention of AI or ML.
No
This device is described as an assayed quality control material and calibration verifier, intended to evaluate the performance of other quality control products on lab systems. It does not directly treat or diagnose a disease or condition in a patient.
No
The device is described as an assayed quality control material and calibration verifiers, which are used to evaluate the performance of other quality control products, not to diagnose a patient's medical condition.
No
The provided text describes liquid quality control materials and calibration verifiers, which are physical substances used in laboratory testing, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the products are "intended for use as an assayed quality control material" and "intended to evaluate the performance of assayed, liquid, quality control products". Quality control materials and calibration verifiers used to assess the performance of diagnostic tests are considered IVDs. They are used in vitro (outside the body) to analyze samples (in this case, the performance of other diagnostic materials).
While the "Device Description" is not found, the "Intended Use" is the primary indicator for determining if a device is an IVD. The fact that it's used to control and verify the performance of other assayed materials strongly points to its role in the diagnostic process.
N/A
Intended Use / Indications for Use
CLINIQA Liquid QC™ TDM Controls Levels 1, 2 & 3 are intended for use as an assayed quality control material.
CLINIQA LiniCAL™ TDM Calibration Verifiers Levels A – E for Olympus AU Systems™ are intended to evaluate the performance of assayed, liquid, quality control products
Product codes
JJX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is facing to the right. The logo is black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 6 2004
Ms. Carol Ruggiero Director of Regulatory Affairs Cliniqa Corporation 1432 South Mission Road Fallbrook, CA 92028
Re: K041898
Ro 11076
Trade/Device Name: CLINIQA Liquid QCTM TDM Controls Levels 1,2&3 CLINIQA LiniCAL™ TDM Calibration Verifiers Levels A- E for Olympus AU Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: July 12, 2004 Received: July 14, 2004
Dear Ms. Ruggiero:
We have reviewed your Section 510(k) premarket notification of intent to market the device w 6 nave 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
1
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and my yourse FDA finding of substantial equivalence of your device to a legally premailed predicated. " Thesults 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, rr you deens op the promotion and advertising of your device, please contact the Office of or questions on atte promice 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 I ou inay 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,
Jean M. Cooper, MS, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Ko41898 510(k) Number (if known):
Device Name: CLINIQA Liquid QC™ TDM Controls Levels 1, 2 & 3
Indications For Use:
Indications i of Ose.
CLINIQA Liquid QC™ TDM Controls Levels 1, 2 & 3 are intended for use as an CENNIQA Elquid QO - TDM Ooklools of Acetaminophen, Amikain, assayed quality control material: Thros a Ethosuximide, Gentamicin, Lidocaine, Lithium, Galbamazephic, Bloopyrainiae, Landon, Primidone, Procainamide, Quinidine, N-Acetyprocamamiac, I nonobalbital, P. Romany in are provided.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Allete Cuts
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation ar
510(k) K041898
3
KO41898 510(k) Number (if known):
Device Name: CLINIQA LiniCAL™ TDM Calibration Verifiers Levels A – E for Olympus AU Systems™.
Indications For Use:
Indications For Ose.
CLINIQA LiniCAL™ TDM Calibration Verifiers Levels A – E for Olympus AU Systems™ are CEINIQA LIfliCAL - TDM Odibraton Vollions as realuate the performance of assayed, liquid, quality oontrol products minophen, Amikacin, Caffeine, Carbamazepine, Ine Olympus AO Systems - 16. 7866am.nop. Lithium, N-Acetylprocainemide, Digoxh, Disopyranhido, Valproic Acid and Vancomycin at five useful concentrations
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(Please DO not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Albert King
Division Sign Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K041898
111