CHEM-CHEX STAT

K961195 · Streck Laboratories, Inc. · JJY · May 15, 1996 · Clinical Chemistry

Device Facts

• Record ID: K961195
• Device Name: CHEM-CHEX STAT
• Applicant: Streck Laboratories, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: May 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Chem-Chex STAT is intended to be used for verifying the accuracy of i-STAT chemistry analyzers used with 6+ test cartridges. Chem-Chex STAT is assayed for Na⁺, Cl⁻, K⁺, BUN, Hgb, Hct, and Glucose.

Device Story

Chem-Chex STAT; stabilized human red blood cell suspension in aqueous buffered medium; packaged in 2.0 mL polyethylene dropper vials. Used as assayed quality control material for i-STAT chemistry analyzers. Enables verification of analyzer and cartridge system performance. Provides positive procedural control for Na⁺, Cl⁻, K⁺, BUN, Hgb, Hct, and Glucose. Used in clinical laboratory settings by technicians/operators. Results compared against expected values to ensure system accuracy; supports clinical decision-making by validating diagnostic test reliability.

Clinical Evidence

Bench testing only. Three studies conducted: 1) lot-to-lot reproducibility and whole blood comparison; 2) within-lot reproducibility; 3) long-term and open-vial stability. Results demonstrated consistent reproducibility (CVs reported) and stability over product dating.

Technological Characteristics

Stabilized human red blood cells in aqueous buffered medium. Packaging: 2.0 mL polyethylene dropper vials with polypropylene screw-top caps. Analyte composition: Na⁺, Cl⁻, K⁺, BUN, Hgb, Hct, Glucose. No electronic or software components.

Indications for Use

Indicated for use by clinical laboratory personnel to verify the accuracy and performance of i-STAT chemistry analyzers and 6+ test cartridges for the analytes Na⁺, Cl⁻, K⁺, BUN, Hgb, Hct, and Glucose.

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

• i-STAT control (K934641)

Submission Summary (Full Text)

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510(k) Summary of Safety and Effectiveness

K961195

MAY 15 1996

510(k) Submitter:
Streck Laboratories, Inc.
14306 Industrial Road
Omaha, Nebraska 68144

Official Correspondent:
Theodore Heise, Ph.D.
Quality Assurance/Regulatory Affairs Manager
[phone]

Date Prepared:
March 26, 1996

Names of Device:
Trade Name: Chem-Chex STAT
Common Name: Assayed chemistry control
Classification Name: Multi-analyte control (§862.1660)
Classification Number: 75JJY

Predicate Device:
i-STAT control (K934641) manufactured for i-STAT Corp.

Description: Chem-Chex STAT is a suspension of stabilized human red blood cells in an aqueous buffered medium. Manufactured in two clinically significant levels, it is packaged in dropper tip polyethylene vials containing 2.0 mL volumes. Closures are injection molded polypropylene screw-top caps. Vials are packaged in polystyrene jars.

Intended Use: Chem-Chex STAT is intended to be used for verifying the accuracy of i-STAT chemistry analyzers used with 6+ test cartridges. Chem-Chex STAT is assayed for Na⁺, Cl⁻, K⁺, BUN, Hgb, Hct, and Glucose.

Comparison with Predicate Device: Like the i-STAT Control, Chem-Chex STAT is intended to enable the user to verify satisfactory performance of the i-STAT analyzer and cartridge system. Both devices are liquid controls containing sodium, chloride, potassium, blood urea nitrogen, and glucose.

Unlike the i-STAT Control, Chem-Chex STAT is an assayed control. This provides the user a complete positive procedural control. In addition, Chem-Chex STAT contains red blood cells and is assayed for hemoglobin and hematocrit. It is not assayed for PCO₂, PO₂, pH, or ionized calcium.

Discussion of Tests and Test Results: Three studies of Chem-Chex STAT were conducted: I) lot to lot reproducibility and comparison with whole blood; II) within lot reproducibility; and III) long term and open vial stability. Study results showed CVA to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating

Conclusions Drawn from Tests: Study results show Chem-Chex STAT to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating. Chem-Chex STAT is a safe and effective product which fulfills its intended use when used as instructed in the product package insert.