(9 days)
The Cardiac Marker Control Module is an assayed, bi-level control module containing analytes (CK-MB, myoglobin, and troponin I) associated with acute myocardial infarction (AMI). It is intended as an aid in monitoring day-to-day assay performance.
DPC's Cardiac Marker Control Module is an assayed, bi-level control intended for use with the IMMULITE CK-MB, IMMULITE Myoglobin, and IMMULITE Troponin I assays.
The provided text does not contain information about explicit acceptance criteria or a study proving the device meets them in the conventional sense of a clinical trial or performance study for an AI/CADe device.
This submission (K983971) is for a "Cardiac Marker Control Module," which is a quality control material, not a diagnostic device that directly interprets patient data. Therefore, the concept of "device performance" in terms of sensitivity, specificity, or reader improvement, as typically applied to AI-powered diagnostic tools, does not apply here.
The summary explicitly states: "Clinical Studies: Not applicable." This further confirms that no such studies were conducted or required for this type of device.
Instead, the submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, which is the standard for 510(k) clearances. Substantial equivalence for this type of product typically involves demonstrating that the control module behaves as expected for its intended purpose (monitoring assay performance) without presenting new safety or efficacy concerns compared to existing controls.
Therefore, the requested information cannot be extracted from this document as it pertains to a different type of medical device and regulatory submission.
{0}------------------------------------------------
510(k) Summary Safety and Effectiveness
This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92
| Name:Address: | Diagnostic Products Corporation5700 West 96th StreetLos Angeles, CA 90045-5597 |
|---|---|
| Telephone Number:Facsimile Number: | (310) 645-8200(310) 645-9999 |
| Contact Person: | Edward M. Levine, Ph.D.Director of Clinical Affairs |
| Date of Preparation: | November 6, 1998 |
| Device Name:Trade: | Cardiac Marker Control ModuleDevice intended as an aid in monitoring the performance of DPC'sIMMULITE® CK-MB, IMMULITE®Myoglobin, and IMMULITE®Troponin I assays |
| Catalog Number: | CCCM |
| Classification: | Class I device, 75-JJY (21 CFR 862.1660) |
| Manufacturer: | Diagnostic Products Corporation5700 West 96th StreetLos Angeles, CA 90045-5597 |
| EstablishmentRegistration #: | DPC's Establishment Registration No. is 2017183 |
| Description of Device: | DPC's Cardiac Marker Control Module is an assayed, bi-levelcontrol intended for use with the IMMULITE CK-MB,IMMULITE Myoglobin, and IMMULITE Troponin I assays. |
| Intended Use of theDevice: | The Cardiac Marker Control Module is an assayed, bi-level controlmodule containing analytes (CK-MB, myoglobin, and troponin I)associated with acute myocardial infarction (AMI). It is intendedas an aid in monitoring day-to-day assay performance. |
| Clinical Studies: | Not applicable |
{1}------------------------------------------------
Conclusion:
The data presented in this summary of safety and effectiveness is the data that the Food and Drug
Administration used in granting DPC substantial equivalence for Module.
Edward A. Reiner
Edward M. Levine, Ph.D. Director of Clinical Affairs
11/6/98
Date
{2}------------------------------------------------
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
NOV 1 8 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Edward M. Levine, Ph.D. Director of Clinical Affairs Diaqnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597
Re: K983971 Cardiac Marker Control Module Trade Name: Requlatory Class: I Product Code: JJX Dated: November 6, 1998 November 9, 1998 Received:
Dear Dr. Levine:
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 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 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 requlation 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.
{3}------------------------------------------------
Page 2
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 Autman
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
{4}------------------------------------------------
1498397 510(k) Number (if known): __ Device Name: Cardiac Marker Control Module
Indications For Use:
The Cardiac Marker Control Module is an assayed, bi-level control module containing analytes (CK-MB, myoglobin, and troponin I) associated with acute myocardial infarction (AMI). It is intended as an aid in monitoring day-to-day assay performance.
(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-
9(6)
(Division Sign-Off)
Division of Clinical Laboratory Devices
10(k) Number: K983971
§ 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.