(29 days)
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No
The document describes a quality control serum for laboratory assays, with no mention of AI or ML technology.
No
This device is for in vitro diagnostic use, specifically for quality control in a clinical chemistry laboratory to monitor immunoassay procedures. It is not applied to a patient for treatment or diagnosis.
No
The device is a quality control serum used to monitor the accuracy and precision of diagnostic procedures, not a diagnostic device itself.
No
The device is described as an "assayed quality control serum" and a "tri-level control," 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 strictly for in vitro diagnostic use".
N/A
Intended Use / Indications for Use
DPC's PSA Control Module is designed for use as an assayed quality control serum in the clinical chemistry laboratory to monitor the accuracy and precision of both the Coat-A-Count PSA IRMA and IMMULITE PSA procedures. They are intended strictly for in vitro diagnostic use
Product codes
JJX
Device Description
DPC's PSA Control Module is an assayed tri-level control intended for use in the quality control of DPC's Coat-A-Count PSA IRMA assav and DPC's IMMULITE PSA assay.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
clinical chemistry laboratory
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The conclusions drawn from the nonclinical tests demonstrate that the device is safe and effective.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
K96 2975
Diagnostic Products Corporation 5700 West 96th Street I os Angeles, CA 90045 (213) 776-0180 el: Fax: (213) 776-0204
2 9 1996
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: | July 26, 1996 |
| Device Name:
Trade: | PSA Control Module
Device intended as an aid in monitoring the performance
of DPC's Coat-A-Count® PSA IRMA assay and the
IMMULITE PSA assay. |
| Catalog Number: | PSACM |
| Classification: | Class I device, 82-JJX (21 CFR 862.1660) |
| Manufacturer: | Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, California 90045-5597 |
| Establishment Registration Number: | DPC's Registration Number is 2017183 |
| Description of Device: | DPC's PSA Control Module is an assayed tri-level
control intended for use in the quality control of DPC's
Coat-A-Count PSA IRMA assav and DPC's IMMULITE
PSA assay. |
| Intended Use of the Device: | DPC's PSA Control Module is designed for use as
an assayed quality control serum in the clinical chemistry
laboratory to monitor the accuracy and precision of both
the Coat-A-Count PSA IRMA and IMMULITE PSA
procedures. They are intended strictly 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.
Edward Levine
Edward M. Levine, Ph.D. Director of Clinical Affairs
7/4/56
Date
Date