(8 days)
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None
No
The summary describes a chemistry control material, which is a reagent used for quality control in laboratory testing, and there is no mention of AI or ML in the provided text.
No.
The device is a chemistry control material used for monitoring the accuracy and precision of clinical chemistry procedures, not for treating any medical condition.
No
Explanation: The device is described as a "Chemistry Control," intended for "monitoring the accuracy and precision of clinical chemistry procedures." This indicates it is used for quality control of lab tests, not for directly diagnosing a patient's medical condition. It helps ensure the diagnostic tests are working correctly, but it is not a diagnostic tool itself.
No
The device is described as "materials" and "Lyophilized Chemistry Control," indicating it is a physical substance used in laboratory procedures, 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 materials are "intended for use in monitoring the accuracy and precision of clinical chemistry procedures." This aligns perfectly with the definition of an IVD, which are used to examine specimens derived from the human body to provide information for diagnostic purposes. While this specific control material isn't directly diagnosing a patient, it's essential for ensuring the reliability of the diagnostic tests themselves.
- Device Description: The description "QUICKCHECK Lyophilized Chemistry Control" further supports its role in a clinical chemistry laboratory setting, which is where IVDs are used.
- Intended User / Care Setting: "clinical chemistry procedures" confirms the context of its use within a clinical laboratory environment.
The absence of information about image processing, AI/ML, imaging modalities, anatomical sites, patient age ranges, training/test sets, performance studies, key metrics, and predicate/reference devices is expected for a control material. These details are more relevant for diagnostic tests themselves, not the materials used to validate those tests.
N/A
Intended Use / Indications for Use
QUICKCHECK CONFORMANCE® Chemistry Control C3 are materials intended for use in monitoring the accuracy and precision of clinical chemistry procedures.
Product codes
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States of America. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three intertwined strands instead of snakes.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 21 1996
E. Kay Robinson · Business Unit Manager-Proficiency Products Consolidated Technoloqies, Inc. 2170 Woodward Street, Suite 100 Austin, Texas 78744-1832
K981339 Re : QUICKCHECK Lyophilized Chemistry Control CONFORMANCE®® Chemistry Control C3 Requlatory Class: I Product Code: JJY Dated: April 9, 1998 Received: April 13, 1998
Dear Ms. Robinson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note:
this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Bitman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use
QUICKCHECK Lyophilized Chemistry Control Device Name: Also Distributed as:
CONFORMANCE® Chemistry Control C3
Control and/or Lyophilized Chemistry Indication for Use: QUICKCHECK CONFORMANCE® Chemistry Control C3 are materials intended for use in monitoring the accuracy and precision of clinical chemistry procedures.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K981339
