← Product Code [JJY](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY) · K965114 # TUMOR MARKER CONTROL (K965114) _Diagnostic Products Corp. · JJY · Feb 20, 1997 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY/K965114 ## Device Facts - **Applicant:** Diagnostic Products Corp. - **Product Code:** [JJY](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY.md) - **Decision Date:** Feb 20, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1660 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## 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. ## Device Story Assayed, tri-level quality control material; used to monitor performance of DPC tumor marker assays; in vitro diagnostic use; provides reference values for assay validation; ensures analytical consistency in clinical laboratory settings. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Assayed, tri-level liquid control material. Manufactured under ISO 9002/EN29002/BS 5750 quality systems. ## 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. ## Predicate Devices - DPC's PSA Control Module ([K962975](/device/K962975.md)) ## 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 Tumor Marker Control Module December 16, 1996 K 965114 # 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: | Diagnostic Products Corporation | | --- | --- | | Address: | 5700 West 96th Street Los Angeles, California 90045-5597 | | Telephone Number: | (213) 776-0180 | | Facsimile Number: | (213) 776-0204 | | Contact Person: | Edward M. Levine, Ph.D. Director of Clinical Affairs | | Date of Preparation: | December 16, 1996 | | Device Name: | Tumor Marker Control | | Trade: | 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 | --- **Source:** [https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY/K965114](https://fda.innolitics.com/submissions/IM/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY/K965114) **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