← Product Code [JIT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT) · K970336

# MMB CALIBRATOR (K970336)

_Dade Chemistry Systems, Inc. · JIT · Mar 3, 1997 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K970336

## Device Facts

- **Applicant:** Dade Chemistry Systems, Inc.
- **Product Code:** [JIT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT.md)
- **Decision Date:** Mar 3, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.1150
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications for 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.

## Regulatory 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)

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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

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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.

![img-0.jpeg](img-0.jpeg)

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

5 000009

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K970336](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K970336)

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