MMB CALIBRATOR

K970336 · Dade Chemistry Systems, Inc. · JIT · Mar 3, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970336
• Device Name: MMB CALIBRATOR
• Applicant: Dade Chemistry Systems, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Mar 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The MMB Calibrator is intended to be used to calibrate the MMB method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.

Device Story

MMB Calibrator; lyophilized horse serum-based product; used to calibrate MMB method on Dimension® RxL clinical chemistry system. Kit contains ten vials across five levels; Level 1 contains no detectable CKMB; Levels 2-5 contain human CKMB. Used in clinical laboratory settings by laboratory personnel to ensure accurate quantification of CKMB analytes by the Dimension® RxL system.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Lyophilized horse serum-based calibrator; five-level kit; 2.0 mL per vial when reconstituted. Designed for use with Dimension® RxL clinical chemistry system heterogeneous immunoassay module.

Indications for Use

Indicated for use as a calibrator for the MMB method on the Dimension® RxL clinical chemistry system to support CKMB analyte measurement.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Abbott Laboratories IMx® Stat CK-MB Calibrator

Submission Summary (Full Text)

{0}

DADE
K 970336
MAR - 3 1997
DADE INTERNATIONAL
Interoffice Memorandum

# Summary of Safety and Effectiveness Information

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:

01/27/1997

## Name of Product:

MMB Calibrator

## FDA Classification Name:

Calibrator

## Predicate Device:

Abbott Laboratories*IMx® Stat CK-MB Calibrator

## Device Description:

The MMB Calibrator is a lyophilized horse serum-based product. The Level 1 calibrator contains no detectable CKMB. Levels 2 through 5 contain human CKMB. The kit consists of ten vials; two at each of five levels.

## Intended use:

The MMB Calibrator is intended to be used to calibrate the MMB method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.

## Comparison to Predicate Device:

| Item | MMB Calibrator | IMx® Stat CK-MB Calibrator |
| --- | --- | --- |
| Intended Use | Calibrator | Calibrator |
| Analytes | CKMB | CKMB |
| Matrix | horse serum | bovine serum |
| Form | lyophilized | liquid |
| Volume | 2.0 mL per vial, reconstituted | 4.0 mL per vial |
| Levels | 5 levels | 6 levels |

* IMx® is a trademark of Abbott Laboratories, Abbott Park, IL 60064

4
000008

{1}

Comments on Substantial

Equivalence: Both the MMB Calibrator for the Dimension® RxL system and the Abbott IMx® Stat CK-MB Calibrator are intended to be used as calibrators for CKMB methods.

Conclusion: The MMB Calibrator is substantially equivalent to the IMx® Stat CK-MB Calibrator based on the comparison discussed above.


Cathy P. Craft
Regulatory Affairs and
Compliance Manager
Date:01/27/1997

5 000009