Who is the manufacturer of MMB CALIBRATOR?

Dade Chemistry Systems, Inc. submitted the Traditional clearance for MMB CALIBRATOR (K970336).

What is the FDA product code for MMB CALIBRATOR?

JIT. It is classified under 21 CFR 862.1150 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for MMB CALIBRATOR?

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

MMB CALIBRATOR

Q: What are the predicate devices for MMB CALIBRATOR?

Abbott Laboratories IMx® Stat CK-MB 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

Related Devices

K062152 — CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27 · Dade Behring, Inc. · Aug 16, 2006
K984193 — DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR · Dade Behring, Inc. · Dec 14, 1998
K083579 — DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360 · Siemens Healthcare Diagnostics · Feb 20, 2009
K981097 — STRATUS CS CKMB CALPAK · Dade Behring, Inc. · Apr 16, 1998
K963182 — ELECSYS CALCHECK CK-MB · Boehringer Mannheim Corp. · Aug 23, 1996

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. ![img-0.jpeg](img-0.jpeg) Cathy P. Craft Regulatory Affairs and Compliance Manager Date:01/27/1997 5 000009