(13 days)
QUALITROL CARDIAC MARKER CONTROL, Levels 1, 2 and 3, is a liquid human serum based assayed quality control material intended to monitor the performance of clinical test procedures that analyze for indicators of possible cardiac abnormalities.
liquid human serum based assayed quality control material
The provided document is a 510(k) clearance letter from the FDA for a medical device called "QUALITROL Cardiac Marker Control, Level 1, 2 and 3". This letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed.
However, this document does not contain the detailed information necessary to describe acceptance criteria and a study proving the device meets those criteria. The 510(k) clearance process focuses on substantial equivalence to a legally marketed predicate device, rather than requiring a detailed clinical study demonstrating device performance against specific acceptance criteria.
The letter mentions the "Indications for Use Statement," which describes what the device is intended to do: "QUALITROL CARDIAC MARKER CONTROL, Levels 1, 2 and 3, is a liquid human serum based assayed quality control material intended to monitor the performance of clinical test procedures that analyze for indicators of possible cardiac abnormalities." This statement defines the purpose of the device, but not its performance acceptance criteria.
Therefore, I cannot provide the requested information based solely on the content of this document. A 510(k) submission typically includes data to support substantial equivalence (e.g., analytical performance studies for in-vitro diagnostic devices), but those specific details are not present in this regulatory clearance letter.
To fully answer your request regarding acceptance criteria and a study proving device performance, I would need access to the actual 510(k) submission data (e.g., the analytical studies like precision, accuracy, stability, etc., that would have been submitted to demonstrate the quality control material itself performs as expected).
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NOV I 6 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Rusty Sewell Product Development Engineer SeraCare Technology, Inc. DBA, Consolidated Technologies 2170 Woodward Street Austin, Texas 78744-1832
Re: K993715
Trade Name: OUALITROL Cardiac MarkerControl, Level 1, 2 and 3 Regulatory Class: I Product Code: JJT Dated: November 3, 1999 Received: November 3, 1999
Dear Mr. Sewell:
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 (OS) 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/cdrh/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
510(k) number (if known): K_ 937/5____________________________________________________________________________________________________________________________________________
Device name:
QUALITROL CARDIAC MARKER CONTROL, Levels 1 and 2
Indications for use:
QUALITROL CARDIAC MARKER CONTROL, Levels 1, 2 and 3, is a liquid human serum based assayed quality control material intended to monitor the performance of clinical test procedures that analyze for indicators of possible cardiac abnormalities.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
Division of Clinical Laboratory Devices
| 510(k) Number | K993715 |
|---|---|
| --------------- | --------- |
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.