← Product Code [JJX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX) · K962975 # PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM) (K962975) _Diagnostic Products Corp. · JJX · Aug 29, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K962975 ## Device Facts - **Applicant:** Diagnostic Products Corp. - **Product Code:** [JJX](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX.md) - **Decision Date:** Aug 29, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1660 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## 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. ## Device Story Assayed tri-level control serum; used in clinical chemistry laboratories; monitors accuracy and precision of DPC Coat-A-Count PSA IRMA and IMMULITE PSA assays; provides quality control verification for in vitro diagnostic procedures. ## Clinical Evidence No clinical data; nonclinical tests demonstrate safety and effectiveness. ## Technological Characteristics Assayed tri-level control serum; in vitro diagnostic quality control material. ## Regulatory 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. ## Reference Devices - Coat-A-Count PSA IRMA assay - IMMULITE PSA assay ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} Diagnostic Products Corporation 5700 West 96th Street Los Angeles, CA 90045 Tel: (213) 776-0180 Fax: (213) 776-0204 K 96 2975 AUG 29 1996 # DPC ## 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: **Device Name:** **Trade:** | July 26, 1996 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: **Classification:** **Manufacturer:** | PSACM Class I device, 82-JJX (21 CFR 862.1660) Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597 | | Establishment Registration Number: **Description of Device:** | DPC's Registration Number is 2017183 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 assay 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: **Conclusion:** | Not applicable | The conclusions drawn from the nonclinical tests demonstrate that the device is safe and effective. Edward M. Levine, Ph.D.
Director of Clinical Affairs 7/26/96 --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K962975](https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/JJX/K962975) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com