← Product Code [JJY](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY) · K955812 # SYSCON TURMOR MARKER CONTROL (K955812) _Scantibodies Laboratory, Inc. · JJY · Mar 12, 1996 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY/K955812 ## Device Facts - **Applicant:** Scantibodies Laboratory, Inc. - **Product Code:** [JJY](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY.md) - **Decision Date:** Mar 12, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1660 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Indications for Use For use as an assayed quality control material to assist in monitoring accuracy and precision in clinical immunoassays used in cancer antigen testing. ## Device Story Two-level, multi-analyte, lyophilized quality control material; derived from human blood with added purified chemicals, human biochemicals, and preservatives. Used in clinical laboratories to monitor accuracy and precision of cancer antigen immunoassays. Provides reference values for assay validation; ensures vial-to-vial consistency and stability. Assists clinicians in verifying performance of diagnostic testing systems. ## Clinical Evidence Nonclinical bench testing only; includes vial-to-vial variability, reconstituted stability, expiration dating, and value assignment protocols. ## Technological Characteristics Lyophilized human blood-based matrix; multi-analyte composition; includes purified chemicals, human biochemicals, and preservatives. Two-level formulation. ## 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 - Dade Special-T Marker (Baxter Diagnostics Inc.) ## 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. 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"SCANTIBODIES FOR ANTIBODIES" K948510 MAR 12 1996 510(k) Summary Submitter: Tom Cantor Scantibodies Laboratory, Incorporated 9336 Abraham Way, Santee, CA 92071-2862 Date: December 15, 1995 Device Name: SysCon (or other brand names) Tumor Marker Control Predicate Device: Dade* Special-T* Marker, manufactured by Baxter Diagnostics Inc. ## Device Description: This is a two level, multi-analyte, lyophilized quality control material prepared from human blood, with added purified chemicals, human biochemicals and preservatives. ## Intended use: For use as an assayed quality control material to assist in monitoring accuracy and precision in clinical immunoassays used in cancer antigen testing. Comparison of the product to the predicate device for intended use, analytes, number of levels, form, diluent, base, additives, microbial content, lot homogeneity and vial-to-vial consistency, stability and reliability of assay values supports a substantial equivalence finding. ## Performance data: Nonclinical tests for vial-to-vial variability, reconstituted stability and expiration dating, as well as value assignment protocols, submitted, referenced, or relied on in the premarket notification submission, support the conclusion that the device is as safe and effective, and performs as well as or better than the legally marketed devices identified in this summary. 9336 Abraham Way • Santee, CA 92071-2862 • (619) 258-9300 Telex 695205 a@SCANTIBODISDG TELEFAX: 619-258-9366 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY/K955812](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJY/K955812) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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