(41 days)
SYSCON IDC-G is a human serum based unassayed control used to monitor analytical procedures and reagents for detecting agents of infectious diseases in patient serum or plasma specimens. These controls are to be used with in vitro immunoassay procedures for the qualitative determination of Chlamydia, Epstein-Barr related antigen, Borrelia burgdorferi, Herpes Complex, Hepatitis, and TORCH. These controls are not to be used as replacements for the kit controls and are not FDA cleared in use for testing blood or plasma donors.
SYSCON IDC-G, NEGATIVE AND POSITIVE is a human serum based unassayed control.
The provided text is a scanned FDA 510(k) clearance letter and an Indications for Use statement for the "SYSCON IDC-G, NEGATIVE AND POSITIVE" device. This type of document does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a device performance study.
The letter acknowledges the submission and states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. The Indications for Use describe what the device is for (monitoring analytical procedures and reagents for detecting infectious disease agents in patient serum or plasma) but does not include any performance metrics or study data.
Therefore, I cannot provide the requested table and information based on the given text.
To answer the user's request, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a detailed product manual that includes performance data.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 4 1997
Richard Lenart Regulatory Affairs Scantibodies Laboratory, Inc. 9336 Abraham Way Santee, CA 92071-2862
Re: K974262 Trade Name: Syscos IDC - G, IDC, BSC, IDC - G Regulatory Class: I Product Code: MJX, MJY Dated: November 11, 1997 Received: November 13, 1997
Dear Mr. Lenart:
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 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 OS 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
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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510 (k) NUMBER (IF KNOWN): K974262
DEVICE NAME: SYSCON IDC-G, NEGATIVE AND POSITIVE
INDICATIONS FOR USE:
SYSCON IDC-G is a human serum based unassayed control used to monitor analytical procedures and reagents for detecting agents of infectious diseases in patient serum or plasma specimens. These controls are to be used with in vitro immunoassay procedures for the qualitative determination of Chlamydia, Epstein-Barr related antigen, Borrelia burgdorferi, Herpes Complex, Hepatitis, and TORCH. These controls are not to be used as replacements for the kit controls and are not FDA cleared in use for testing blood or plasma donors.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
| Concurrent of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Sally ? Selezaker | |
| Prescription Use | ✓ |
| (Per 21 CFR 801.109 | |
| OR acting for Over-The-Counter-Use _____ | |
| John Tichiniut (Optional Format 1-2-96) | |
| at Laboratory Devices |
§ 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.