(62 days)
Not Found
No
The summary describes a quality control material for tumor marker assays, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
Explanation: The device is explicitly stated as being "strictly for in vitro diagnostic use," meaning it is used for testing samples outside the body to diagnose diseases, not to treat them. It is a control module for tumor marker assays.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "It is intended strictly for in vitro diagnostic use."
No
The device is described as a "Quality Control Material" and "assayed, tri-level control," which are physical substances used for quality control in laboratory assays, not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "It is intended strictly for in vitro diagnostic use."
- Device Description: The device is described as "Quality Control Material," which is a common type of product used in in vitro diagnostic testing to ensure the accuracy and reliability of the assays.
- Intended Use with IVD Assays: The control module is intended for use with "DPC's tumor marker assays," which are themselves in vitro diagnostic tests.
These points strongly indicate that the device is designed and intended for use in laboratory settings to perform diagnostic tests on samples taken from the human body (in vitro).
N/A
Intended Use / Indications for Use
DPC's Tumor Marker Control Module is an assayed, tri-level control intended for use with DPC's tumor marker assays. It is intended strictly for in vitro diagnostic use.
Product codes
JJY
Device Description
Quality Control Material
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
K 965114
Diagnostic Products Corporation Tumor Marker Control Module December 16, 1996
FEB 20 1997
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, California 90045-5597 |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number:
Facsimile Number: | (213) 776-0180
(213) 776-0204 |
| Contact Person: | Edward M. Levine, Ph.D.
Director of Clinical Affairs |
| Date of Preparation: | December 16, 1996 |
| Device Name:
Trade: | Tumor Marker Control
Device intended as an aid in monitoring the performance
of DPC's tumor marker assays. |
| Catalog Number: | TMCO |
| Classification: | Class I device, 75-JJY (21 CFR 862.1660) |
| Manufacturer: | EURO/DPC Ltd., a wholly-owned subsidiary of DPC
Glyn Rhonwy
Llanberis, Gwynedd LL55 4EL
United Kingdom
(Manufacturing under a Quality System-ISO
9002/EN29002/BS 5750) |
| Sole U.S. Importer: | Diagnostic Products Corporation (DPC)
5700 West 96th Street
Los Angeles, CA 90045-5597 |
| Establishment
Registration #: | EURO/DPC: Not Applicable
DPC: 2017183 |
| Substantially
Equivalent
Predicate Device: | DPC's PSA Control Module (K962975) |
| Description of Device: | Quality Control Material |
| Intended Use of the Device: | DPC's Tumor Marker Control Module is an
assayed, tri-level control intended for use with DPC's
tumor marker assays. It is intended strictly for in
vitro diagnostic use. |
| Clinical Studies: | Not applicable |
.