(32 days)
The K-ASSAY Apo A1/B Calibrator Set is intended to be used for the calibration of the K-ASSAY APO A1/B immunoturbidimetric assay for quantitating APO A1/B in serum samples.
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "K-ASSAY Apo A1/B Calibrator Set." It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter simply states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It provides "INDICATIONS FOR USE STATEMENT" (page 2) which clarifies the intended purpose of the device: "The K-ASSAY Apo A1/B Calibrator Set is intended to be used for the calibration of the K-ASSAY APO A1/B immunoturbidimetric assay for quantitating APO A1/B in serum samples."
The document does not include any of the following information:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information on a standalone algorithm performance study.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 26 1999
Mr. Colin Getty Official Correspondent Kamiya Biomedical Company 910 Industry Drive Seattle, Washington 98188
K993606 Re:
Trade Name: K-ASSAY Apo A1/B Calibrator Set Regulatory Class: II Product Code: JIX Dated: October 15, 1999 Received: October 25, 1999
Dear Mr. Getty:
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 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). 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 (Premarket Approval), 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 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 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 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/cdrl/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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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INDICATIONS FOR USE STATEMENT
K9936060 510(k) Number (if known):
Device Name: K-ASSAY Apo A1/B Calibrator Set.
Indications for Use:
The K-ASSAY Apo A1/B Calibrator Set is intended to be used for the calibration of the K-ASSAY APO A1/B immunoturbidimetric assay for quantitating APO A1/B in serum samples.
Jean Cooger
(Division Sign-Off)
Division of Clinical Laboratory Devices
$10(k) Number K993606
(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.