SYSCON TURMOR MARKER CONTROL

K955812 · Scantibodies Laboratory, Inc. · JJY · Mar 12, 1996 · Clinical Chemistry

Device Facts

• Record ID: K955812
• Device Name: SYSCON TURMOR MARKER CONTROL
• Applicant: Scantibodies Laboratory, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

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.

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.

Indications for Use

Indicated for use as an assayed quality control material for monitoring accuracy and precision in clinical immunoassays for cancer antigen testing in clinical laboratory settings.

Regulatory Classification

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)

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# SCANTIBODIES LABORATORY, INC.

"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 • [phone]
Telex 695205 a@SCANTIBODISDG TELEFAX: 619-258-9366