(40 days)
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Not Found
No
The document describes chemistry controls and calibrators, which are standard laboratory reagents, and contains no mention of AI or ML.
No
Explanation: The device is intended for use as quality control material and calibrators for chemical analyzers, not for treating or diagnosing any medical condition.
No
The document describes quality control materials and calibrators for clinical chemistry analyzers, which are used to ensure the accuracy of assays, not to diagnose a disease or condition in a patient.
No
The provided text describes chemical control and calibrator materials, which are physical substances used in laboratory testing, not software.
Yes, based on the provided information, these devices are IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use statements clearly indicate that these products are used for quality control and calibration in the context of clinical chemistry analyzers. These are activities performed in vitro (outside the body) on biological samples (like blood or urine, though not explicitly stated, this is the typical context for clinical chemistry).
- Device Types:
- CLINIQA Dry QC™ Chemistry Control: Quality control materials are used to verify the accuracy and precision of diagnostic tests. This is a core function of IVDs.
- CLINIQA QALIBRATE™ - CH Chemistry Calibrator: Calibrators are used to establish the relationship between the signal measured by a diagnostic instrument and the concentration of the analyte being measured. This is also a fundamental component of many IVD systems.
The fact that the "Device Description" is "Not Found" and other sections like "Mentions image processing," "Mentions AI," etc., are also "Not Found" doesn't negate their IVD status. These sections are often more relevant for complex diagnostic devices that involve image analysis or AI algorithms. Quality control materials and calibrators are typically simpler in their function but are still essential components of the in vitro diagnostic process.
N/A
Intended Use / Indications for Use
CLINIQA Dry QC™ Chemistry Control, Levels 1 and 2 (Assayed ), is intended for use as an assayed quality control material. Two levels of the control are provided.
CLINIQA Dry QC™ Chemistry Control, Levels 1 and 2 (Unassayed) is intended for use as a quality control material. Two levels of the control are provided.
CLINIQA QALIBRATE™ - CH Chemistry Calibrator is intended for use in assay method calibration for clinical chemistry analyzers.
Product codes
JIT, JJY
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)
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
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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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 its wings spread, enclosed within a circle. The text "HEALTH & HUMAN SERVICES - USA" is arranged around the circle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 1 2006
Ms. Carol Ruggiero Director of Regulatory Affairs Cliniqa Corporation 1432 South Mission Rd. Fallbrook, CA 92028
Re: K060322
Trade/Device Name: CLINIQA Dry QC™ Chemistry Control, Levels 1 and 2, Assayed CLINIOA Dry QC™ Chemistry Control, Levels 1 and 2, Unassayed CLINIQA QUALIBRATE™- CH Chemistry Calibrator Regulation Number: 21 CFR§ 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class II Product Code: JIT, JJY Dated: February 3, 2006 Received: February 9, 2006
Dear Ms. Ruggiero:
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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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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto Garcia
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology 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: CLINIQA Dry QC™ Chemistry Control, Levels 1 and 2, Assayed
Indications For Use:
CLINIQA Dry QC™ Chemistry Control, Levels 1 and 2 (Assayed ), is intended for use as an assayed quality control material. Two levels of the control are provided.
Device Name: CLINIQA Dry QC™ Chemistry Control, Levels 1 and 2, Unassayed
Indications For Use:
CLINIQA Dry QC™ Chemistry Control, Levels 1 and 2 (Unassayed) is intended for use as a quality control material. Two levels of the control are provided.
Device Name: CLINIQA QALIBRATE™ - CH Chemistry Calibrator
Indications For Use:
CLINIQA QALIBRATE™ - CH Chemistry Calibrator is intended for use in assay method calibration for clinical chemistry analyzers .
X 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)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety