(29 days)
LiniCAL™ hsCRP Calibration Verifiers Levels A – E for Olympus AU Systems™ is intended for use as an assayed quality control material for analysis.
Not Found
This FDA document is a 510(k) clearance letter for the device "LiniCAL™ hsCRP Calibration Verifiers Levels A – E for Olympus AU Systems™". It states that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain the specific information required to answer your questions about acceptance criteria and the study proving the device meets those criteria.
Here's why and what information is missing:
- Substantial Equivalence: A 510(k) clearance is primarily about demonstrating "substantial equivalence" to a predicate device. It usually relies on comparing device features, intended use, and performance data to an already cleared device. It doesn't typically require a detailed, de novo study with explicit acceptance criteria and corresponding performance metrics for this specific device in the way you've outlined for clinical or diagnostic AI systems.
- Device Type: The device described is a "quality control material" for a diagnostic system (hsCRP calibration verifiers). Its performance is typically assessed by its stability, homogeneity, and its ability to consistently calibrate a diagnostic instrument within defined ranges, not by diagnostic accuracy metrics like sensitivity, specificity, or AUC, which are common for AI-driven diagnostic tools.
Therefore, I cannot provide the requested information from this document.
To answer your questions, I would need a different type of document, such as:
- A clinical study report for a diagnostic device.
- A validation report for an AI/ML medical device.
- The actual 510(k) submission document itself, which might contain a summary of the performance data, though often in the context of comparison to a predicate rather than against pre-defined acceptance criteria for a novel clinical claim.
If you can provide a document that describes a specific study with acceptance criteria and device performance evaluation, I would be happy to analyze it for you according to your outlined points.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 7 2002
Ms. Carol Ruggiero Director of Regulatory Affairs CLINIOA Corporation 1432 South Mission Road Fallbrook, CA 92028
Re: K022491
Trade/Device Name: LiniCAL™ hsCRP Calibration Verifiers Levels A – E for Olympus AU Systems™
Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: July 25, 2002 Received: July 29, 2002
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. 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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" (21CFR 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/dsmaldsmamain.html".
Sincerely yours,
Steven Putman
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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0224 510(k) Number (if known):
Device Name: LiniCAL™ hsCRP Calibration Verifiers Levels A - E for Olympus AU Systems ™
Indications For Use:
LiniCAL™ hsCRP Calibration Verifiers Levels A – E for Olympus AU Systems™ is intended for use as an assayed quality control material for analysis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Toronica D. Celcie for Dan Cooper
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 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.