(90 days)
Clinical laboratories, performing quantitative or semi-quantitative tests to determine alpha fetoprotein (AFP) in patient specimen and desiring to use the quality control material that is not provided with the kit used for such measurement, may use Qualitrol AFP Control Set as an alternative. Compattibility among the test reagents and Qualitrol AFP Control Set needs to be established prior to such a use.
Not Found
This document is an FDA 510(k) clearance letter for a quality control material, the "Qualitrol, Alpha Fetoprotein (AFP) Control Set."
Such documents do not typically include details about acceptance criteria, device performance studies, or ground truth establishment in the way requested for AI/machine learning devices. This 510(k) is for an in-vitro diagnostic quality control product, not a device that directly analyzes patient data to provide a diagnosis or prediction.
Therefore, the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) cannot be extracted from this document.
The document primarily focuses on:
- Confirming substantial equivalence to a predicate device.
- Listing regulatory information (regulation number, product code, regulatory class).
- Providing general FDA compliance requirements for the manufacturer.
- Stating the intended use of the device.
To answer your questions for this type of product, one would need to consult the original 510(k) submission summary or technical file, which would detail the analytical performance studies demonstrating the control material's stability, homogeneity, and assigned values, rather than clinical performance against a disease state.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
'APR 28 2009
Mr. William Cone Regulatory Affairs Consolidated Technologies, Inc. 2170 Woodward, Suite 100 Austin, Texas 78744-1832
Re: K961912
Trade/Device Name: Qualitrol, Alpha Fetoprotein (AFP) Control Set Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control materials (assayed and unassayed) Regulatory Class: I Product Code: JJY Dated: July 26, 1996 Received: July 29, 1996
Dear Mr. Cone:
This letter corrects our substantially equivalent letter of August 15, 1996.
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 (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 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
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Page 2 -- Mr. William Cone
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Immunology and Hematology Devices at (240) 276-0493. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
ia m Chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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K961912 510(k) Number (if known): _
Device Name:_Qualitrol AFP Control Set
Indications For Use:
Clinical laboratories, performing quantitative or semi-quantitative tests to determine alpha fetoprotein (AFP) in patient specimen and desiring to use the quality control material that is not provided with the kit used for such measurement, may use Qualitrol AFP Control Set as an alternative. Compattibility among the test reagents and Qualitrol AFP Control Set needs to be established prior to such a use.
Peter E. Marino
(Division Sign-Off)
Division of Clinical Laboratory Devlope
510(k) Number ka 6 913
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.