(33 days)
K/DEN number is not present in the text.
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No
The summary describes a chemical calibrator product, not a software or imaging device, and there are no mentions of AI, ML, or related concepts.
No
The device is a calibrator for a clinical chemistry system, used to ensure the accuracy of measurements. It is not directly used to treat or diagnose a disease or condition in a patient.
No
The device is described as a calibrator used to calibrate a clinical chemistry system, not as a device that directly diagnoses a disease or condition.
No
The device description clearly states it is a "lyophilized horse serum-based product" and a "kit consisting of ten vials," indicating it is a physical, chemical reagent product, not software.
Based on the provided information, the MMB Calibrator is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's used to calibrate a method for a "clinical chemistry system." This indicates it's used in a laboratory setting to analyze biological samples (likely blood or serum, given the "horse serum-based product" description).
- Device Description: It's a "lyophilized horse serum-based product" containing human CKMB. This is a reagent designed to interact with a biological sample or a system that analyzes biological samples.
- Predicate Device: The mention of a "Predicate Device" which is an "IMx® Stat CK-MB Calibrator" strongly suggests that this device is also a calibrator used in a similar diagnostic context. Calibrators are essential components of many IVD tests.
While the document doesn't explicitly use the term "IVD," the intended use and nature of the device clearly align with the definition of an In Vitro Diagnostic device, which is a medical device used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / 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.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Abbott Laboratories*IMx® Stat CK-MB Calibrator
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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. 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
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