MMB METHOD

K970343 · Dade Chemistry Systems, Inc. · JHY · Feb 14, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970343
• Device Name: MMB METHOD
• Applicant: Dade Chemistry Systems, Inc.
• Product Code: JHY · Clinical Chemistry
• Decision Date: Feb 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1215
• Device Class: Class 2

Indications for Use

The MMB Method for the Dimension® RxL Clinical Chemistry System with the heterogeneous immunoassay module is used to quantitatively measure CKMB in human serum and plasma.

Device Story

One-step enzyme immunoassay; sandwich principle. Input: human serum/plasma sample. Process: sample incubated with chromium dioxide particles coated with anti-CKB monoclonal antibodies and β-galactosidase-labeled anti-CKMB monoclonal antibodies; magnetic separation/washing removes unbound components; chromogenic substrate (CPRG) added; hydrolysis releases chromophore (CPR). Output: color change measured at 577 nm, proportional to CKMB concentration. Used in clinical chemistry laboratories; operated by laboratory technicians. Results used by physicians to assess CKMB levels, aiding in clinical decision-making related to cardiac status.

Clinical Evidence

Split-sample comparison of 137 clinical patient samples (range 0.2–283.4 ng/mL) between MMB Method and Abbott IMx® Stat CK-MB. Results: correlation coefficient 0.998, slope 0.845, intercept 0.496 ng/mL.

Technological Characteristics

Sandwich enzyme immunoassay; chromium dioxide particles; monoclonal antibodies; β-galactosidase label; chromogenic substrate (CPRG); colorimetric detection at 577 nm and 700 nm; magnetic separation.

Indications for Use

Indicated for the quantitative measurement of CKMB in human serum and plasma for clinical chemistry analysis.

Regulatory Classification

Identification

A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Predicate Devices

• Abbott Laboratories IMx® Stat CK-MB

Submission Summary (Full Text)

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DADE
K970343
DADE INTERNATIONAL
Interoffice Memorandum

# Summary of Safety and Effectiveness Information

FEB 14 1997

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

**Submitter's Name:**
Cathy P. Craft
Dade International Inc.
P.O. Box 6101
Newark, DE 19714-6101

**Date of Preparation:**
01/27/97

**Name of Product:**
MMB Method for the Dimension® RxL Clinical Chemistry System

**FDA Classification Name:**
Creatine Kinase or Isoenzyme Test System

**Predicate Device:**
Abbott Laboratories IMx® Stat CK-MB

**Device Description:** The MMB Method for the Dimension® RxL Clinical Chemistry System is a one-step enzyme immunoassay based on the "sandwich" principle. Sample is incubated with chromium dioxide particles, coated with monoclonal antibodies specific for the CKB subunit, and conjugate reagent (β-galactosidase labeled monoclonal antibodies specific for CKMB isoenzyme). A particle-CKMB -conjugate sandwich forms during the incubation period. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound β-galactosidase is combined with a chromogenic substrate chlorophenol red-β-d-galactopyranoside (CPRG). Hydrolysis of CPRG releases a chromophore (CPR). The color change at 577 nm is directly proportional to the concentration of CKMB in the original sample.

**Intended Use:** The MMB Method for the Dimension® RxL Clinical Chemistry System with the heterogeneous immunoassay module is used to quantitatively measure CKMB in human serum and plasma.

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Comparison to Predicate
Device:

| Item | Dimension® RxL MMB | Imx® Stat CK-MB |
| --- | --- | --- |
| Technology | Sandwich format
monoclonal antibody
immunoassay | Sandwich format
monoclonal antibody
immunoassay |
| Detection | Colorimetric rate
measurement at 577nm
and 700nm | Fluorometric endpoint
measurement |

Comments on Substantial

Equivalence: Split sample comparison between the MMB Method for the Dimension® RxL clinical chemistry system and the Abbott IMx® Stat CK-MB assay gave a correlation coefficient of 0.998, slope of 0.845, and an intercept of 0.496 ng/mL when tested with 137 clinical patient samples ranging from 0.2 - 283.4 ng/mL.

Conclusion: The MMB Method for the Dimension® RxL clinical chemistry system is substantially equivalent in principle and performance to the Abbott IMx® Stat CK-MB Assay based on the split sample comparison discussed above.

Cathy P. Craft
Regulatory Affairs and
Compliance Manager
Date:01/27/97

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