(20 days)
No
The document describes a control module for a PSA assay, which is a laboratory reagent used for quality control. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No
This device is described as a control module for PSA assays, intended for monitoring assay performance, not for treating any condition or disease.
No
The device is a control module for PSA assays, used to monitor assay performance, not to diagnose a condition in a patient.
No
The device description clearly states it is a "Control Module," which is a physical component used in laboratory assays, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring day-to-day assay performance" with specific in vitro diagnostic assays (IMMULITE and IMMULITE 2000 Third Generation PSA assays). This is a classic function of an IVD control.
- Device Description: The description reinforces that it's an "assayed, tri-level PSA control intended for use with both the IMMULITE® and IMMULITE 2000® Third Generation PSA assays." Controls are essential components of many IVD systems.
The fact that it's a control used with IVD assays to ensure their proper function firmly places it within the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
DPC's IMMULITE® Third Generation PSA Control Module is an assayed, tri-level PSA control intended for use with the IMMULITE and IMMULITE 2000 Third Generation PSA assays. It is intended as an aid in monitoring day-to-day performance.
Product codes
JJY
Device Description
DPC's IMMULITE® Third Generation PSA Control Module is an assayed, tri-level PSA control intended for use with both the IMMULITE® and IMMULITE 2000® Third Generation PSA assays.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Studies: Not applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows a handwritten sequence of characters. The sequence starts with the letter 'K', followed by the number '9', then '8', '1', '4', '5', and ends with '5'. The characters are written in a simple, slightly irregular style, giving them a casual, handwritten appearance.
MAY | 3 1998
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 Corporation
5700 West 96th Street
Los Angeles, CA 90045-5597
ri |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number:
Facsimile Number: | (213) 776-0180
(213) 776-0204 |
| Contact Person: | Edward M. Levine, Ph.D.
Director of Clinical Affairs |
| Date of Preparation: | April 21, 1998 |
| Device Name:
Trade: | IMMULITE® Third Generation PSA Control Module
Device intended as an aid in monitoring the performance of DPC's
Third Generation PSA assays |
| Catalog Number: | LUPCM |
| Classification: | Class I device, 75-JJY (21 CFR 862.1660) |
| Manufacturer: | Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, CA 90045-5597 |
| Establishment
Registration #: | DPC's Establishment Registration No. is 2017183 |
| Description of Device: | DPC's IMMULITE® Third Generation PSA Control Module is an
assayed, tri-level PSA control intended for use with both the
IMMULITE® and IMMULITE 2000® Third Generation PSA
assays. |
| Intended Use of the
Device: | DPC's IMMULITE® Third Generation PSA Control Module is an
assayed, tri-level PSA control intended for use with the
IMMULITE and IMMULITE 2000 Third Generation PSA assays.
It is intended as an aid in monitoring day-to-day 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 againting DPC substantial equivalence for IMMULITE® T Generation PSA Control Module.
Edwin h. Land
Edward M. Levine, Ph.D. Director of Clinical Affairs
Hril/18
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 3 1998
Edward M. Levine, Ph.D. Director of Clinical Affairs Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045
Re: K981455 Trade Name: IMMULITE® Third Generation PSA Control Module Regulatory Class: I Product Code: JJY Dated: April 21, 1998 Received: April 23, 1998
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 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 requirement, 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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Page 2
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 ... ... ... ... .. . . . . . . . . . . . . . . . . . . . .
4
510(k) Number (if known): K972021
Device Name: IMMULITE® Third Generation PSA Control Module
Indications For Use:
(
了
IMMULITE Third Generation PSA Control Module is an assayed, tri-level PSA control intended for use with IMMULITE and IMMULITE 2000 Third Generation PSA assays. 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)
OR
Peter E. Malm
Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number
Prescription Use _ (Per 21 CFR 801:109) -- ------------------------------------------------------------------------------------------------------------------------------------------------------
Over-The-Counter Use_
(Optional Format 1-2-96)