(57 days)
Not Found
Not Found
No
The document describes quality control serum for a laboratory assay and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is described as an "assayed quality control serum" and is intended "strictly for in vitro diagnostic use" to monitor the accuracy and precision of a procedure, not to treat, diagnose, or mitigate disease in a patient.
No
The device description clearly states "DPC's PSA Controls are assaved tri-level controls intended for use in the quality control of DPC's Coat-A-Count PSA IRMA." This indicates it's used for quality control, not for directly diagnosing a patient. Its intended use also specifies "to monitor the accuracy and precision," which is a quality control function.
No
The device description clearly states it is a "quality control serum" and "assayed tri-level controls," indicating it is a physical substance used for quality control, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "They are intended strictiv for in vitro diagnostic use."
N/A
Intended Use / Indications for Use
Device intended as an aid in monitoring the performance of DPC's Coat-A-Count® PSA IRMA.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
DPC's PSA Controls are assaved tri-level controls intended for use in the quality control of DPC's Coat-A-Count PSA IRMA.
DPC's PSA Controls are designed for use as an assaved quality control serum in the clinical chemistry laboratory to monito, the accuracy and precision of the Coat-A-Count PSA IRMA procedure. They are intended strictiv for in vitro diagnostic use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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)
Not applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Diagnostic Products Corporation
MAR 13 East
K. 9600154
510 (k) Summary Safety and Effectiveness
This summary of safety and effectiveness information has heen prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807 92.
Name: Address:
Telephone Number: Facsimile Number: Contact Person:
Date of Preparation: Device Name: Trade:
Catalog Number: Classification: Manufacturer:
Establishment Registration Number: Description of Device:
Intended Use of the Device:
Diagnostic Products Corporation 5700 West 96th Street Los Angeles. California 90045-5597
(213) 776-0186 (213) 776-0204
Edward M. Levine. Ph.D. Manager of Clinical Affairs Januar 12, 1996
PSA Controls Device intended as an aid in monitoring the performance of DPC's Coat-A-Count® PSA IRMA.
PSAC i. PSAC2. PSAC3
Class I dovice, 82-JJX (21 CFR 862.1660)
Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597
DPC's Registration Number is 2017183
DPC's PSA Controls are assaved tri-level controls intended for use in the quality control of DPC's Coat-A-Count PSA IRMA.
DPC's PSA Controls are designed for use as an assaved quality control serum in the clinical chemistry laboratory to monito, the accuracy and precision of the Coat-A-Count PSA IRMA procedure. They are intended strictiv for in vitro diagnostic use.
Clinical Studies:
Not applicable
Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the device is safe and effective.
Sdward L. Keiser
Edward M. Levine, Ph.D. Manager of Clinical Affairs
Date
2/96
D3