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
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.
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
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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.
Cathy P. Craft
Regulatory Affairs and
Compliance Manager
Date:01/27/1997
5 000009
