(30 days)
The Ammonia/Iron Standard Kit 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.
Not Found
The provided document is a 510(k) clearance letter from the FDA for an "Iron Standard Kit" (later referred to as "Ammonia/Iron Standard Kit"). This type of document does not contain the detailed study information required to answer your questions about device performance, acceptance criteria, ground truth establishment, sample sizes, or expert qualifications.
The letter explicitly states: "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...". This means the device was cleared based on its equivalence to a legally marketed predicate device, not necessarily on a full clinical trial demonstrating novel performance against defined acceptance criteria.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This information is typically found in the 510(k) submission itself, not in the clearance letter.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is an "Iron Standard Kit," which is a calibration or reference material, not an AI-powered diagnostic or imaging device. Therefore, an MRMC study is not relevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant for this type of device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present for performance assessment in the context you're asking. For a standard, its "ground truth" would relate to its certified concentration or purity, which would be established by analytical methods, not expert consensus or pathology on human specimens.
- The sample size for the training set: Not relevant for a standard kit.
- How the ground truth for the training set was established: Not relevant for a standard kit.
The letter's key information is that the device (Iron Standard Kit) is "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." Its clearance is based on substantial equivalence, implying it functions similarly to existing, cleared iron standard kits.
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JUL 2 3 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Anthony J. DiMonte President Verichem Laboratories, Inc. -90 Narragansett Avenue 02907 Providence, Rhode Island
Re: K972333 Iron Standard Kit Requlatory Class: II Product Code: JIX June 18, 1997 Dated: Received: June 23, 1997
Dear Mr. DiMonte:
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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices. General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 Requlations.
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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 Gutman
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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PAGE _ of _
510(k) Number (if known): K972333
Device Name: AMMONIA/IRON STANDARD KIT
Indications For Use : .
The Ammonia/Iron Standard Kit 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.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K972333
(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)
§ 862.1150 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.