(12 days)
The Roche Control Serum N and P are in vitro diagnostic devices intended for use as assayed quality control material to monitor the accuracy and precision at normal and pathological levels in quantitative clinical chemistry assays.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA for "Roche Control Serum N (human) and P (human)". It indicates that the device has been found substantially equivalent to predicate devices. However, this document does not contain information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a device performance study.
The document states the "Indications for Use" for the device:
"The Roche Control Serum N and P are in vitro diagnostic devices intended for use as assayed quality control material to monitor the accuracy and precision at normal and pathological levels in quantitative clinical chemistry assays."
As this is a quality control material and not a diagnostic device itself that measures a biological parameter, the concept of "accuracy" and "precision" for this product would refer to its own stated values and consistency, which is different from clinical diagnostic performance metrics like sensitivity or specificity.
Therefore, I cannot provide the requested information from the provided text as it is not present in the document.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 4 1997
James W. Haynes Regulatory Affairs Associate Roche Diagnostic Systems, Inc. 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771
Re : K972214 Roche Control Serum N (human) and P (human) Regulatory Class: I Product Code: JJY June 10, 1997 Dated: Received: June 12, 1997
Dear Mr. Haynes:
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, Druq, 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, qood 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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 requlation (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 requlation 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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| MON 14:48 FAX 908 253 7547 | |
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| Page 1 of 1 | |
| 510(k) Number (if known) | |
| Device Name: | Roche Control Serum N (human)Roche Control Serum P (human) |
| Indications for Use: | The Roche Control Serum N and P are in vitro diagnostic devices intended for use as assayed quality control material to monitor the accuracy and precision at normal and pathological levels in quantitative clinical chemistry assays. |
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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 | K972214 | |
| 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.