(33 days)
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.
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.
The provided text is a summary of safety and effectiveness information for the MMB Calibrator, a medical device used to calibrate a clinical chemistry system for CKMB (Creatine Kinase-MB) testing. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for a diagnostic performance. Therefore, I cannot provide the requested information.
The document does not contain:
- A table of acceptance criteria and reported device performance.
- Details about sample size, data provenance, number of experts, or adjudication methods for a test set.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- The type of ground truth used.
- Sample size for a training set or how its ground truth was established.
The document primarily describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence based on similar characteristics like intended use, analytes, and general nature as a calibrator.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the word "DADE" in large, bold, black capital letters. The font appears to be a serif typeface, with thick strokes and distinct serifs at the ends of the letterforms. The letters are closely spaced, creating a solid block of text.
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. CraftDade International Inc.P.O. Box 6101Newark, 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
0000008
{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.
-141 Proth
Cathy P. Craft Regulatory Affairs and Compliance Manager Date:01/27/1997
000009
§ 862.1150 Calibrator.
(a)
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.)(b)
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.