Who is the manufacturer of MMB METHOD?

Dade Chemistry Systems, Inc. filed the 510(k) submission for MMB METHOD (K970343).

What is the FDA product code for MMB METHOD?

JHY. It is classified under 21 CFR 862.1215 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for MMB METHOD?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like MMB METHOD?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MMB METHOD

Q: What are the predicate devices for MMB METHOD?

Abbott Laboratories IMx® Stat CK-MB.

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

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.

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

Related Devices

K120326 — AQT90 FLEX CKMB TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LEVELS 1-3, AQT90 FLEX CKMB CAL CARTRIDGE · Radiometer Medical Aps · Nov 21, 2012
K234005 — Access CK-MB · Beckman Coulter, Inc. · Feb 16, 2024
K132571 — ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY · Roche Diagnostics · Oct 18, 2013
K030012 — CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372 · Beckman Coulter, Inc. · Jan 17, 2003
K962126 — ACS CKMB II IMMUNOASSAY · Ciba Corning Diagnostics Corp. · Jun 21, 1996

Submission Summary (Full Text)

{0} 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. 000010 {1} 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 000011