(90 days)
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No
The summary describes a quality control material for laboratory tests and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
This device is a quality control material used for laboratory testing, not a device intended for treating diseases or conditions.
No
Explanation: This device is described as a quality control material used to determine alpha fetoprotein (AFP) in patient specimens. It is not used to diagnose a condition, but rather to ensure the accuracy of diagnostic tests.
No
The device is described as a "quality control material" for laboratory tests, which is a physical substance, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for "Clinical laboratories, performing quantitative or semi-quantitative tests to determine alpha fetoprotein (AFP) in patient specimen". This involves testing patient specimens in vitro (outside the body) to obtain diagnostic information (determining AFP levels).
- Device Type: The device is described as a "quality control material". Quality control materials for diagnostic tests are a type of IVD accessory or component used to ensure the accuracy and reliability of the diagnostic test itself.
Therefore, the Qualitrol AFP Control Set, as described, fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
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
Clinical laboratories
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 U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
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)