(16 days)
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No
The description details a standard immunoassay method based on chemical reactions and optical detection, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device measures CKMB in human serum and plasma, which is a diagnostic function rather than a therapeutic one. It provides information for diagnosis and treatment decisions but does not directly treat or prevent a disease.
Yes
The device is described as a method to "quantitatively measure CKMB in human serum and plasma," which is a diagnostic function to assess the levels of a specific biomarker in patient samples.
No
The device description clearly outlines a hardware-based immunoassay system involving chemical reactions, magnetic separation, and optical detection, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "quantitatively measure CKMB in human serum and plasma." This is a measurement performed in vitro (outside the body) on biological samples.
- Device Description: The description details a laboratory-based immunoassay method involving chemical reactions and measurements on a clinical chemistry system. This is characteristic of an in vitro diagnostic test.
- Sample Type: The device uses "human serum and plasma," which are biological samples commonly used in in vitro diagnostic testing.
The information provided clearly indicates that this device is designed to perform a diagnostic test on biological samples outside of the human body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MMB Method for the Dimension® RxL Clinical Chemistry System with the heterogeneous immunoassay module is used to quantitatively measure CKMB in human serum and plasma.
Product codes
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Device Description
The MMB Method for the Dimension® RxL Clinical Chemistry System is a one-step enzyme immunoassay based on the "sandwich" princible. Sample is incubated with chromium dioxide particles, coated with monoclonal anitbodies specific for the CKB subunit, and conjugate reagent (Bgalactosidase labeled monoclonal antibodies specific for CKMB isoenzyme). A particle-CKMB -coniugate sandwich forms during the incubation period. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound ß-galactosidase is combined with a chromogenic substrate chlorophen! red-ß-d-galopyranoside (CPRG). Hydrolysis of CPRG releases a chromophore (CPR). The color change at 577 nm is directly proportional to the concentration of CKMB in the original sample.
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
Split sample comparison between the MMB Method for the Dimension® RxL clinical chemistry system and the Abbott IMx® Stat CK-MB assay gave a correlation coefficient of 0.998, slope of 0.845, and an intercept of 0.496 ng/mL when tested with 137 clinical patient samples ranging from 0.2 -283.4 ng/mL.
Key Metrics
Correlation coefficient: 0.998, slope: 0.845, intercept: 0.496 ng/mL
Predicate Device(s)
Abbott Laboratories IMx® Stat CK-MB
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the word "DADE" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The letters are evenly spaced and aligned horizontally.
Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters, which appear to be 'K970343'. The characters are written in a bold, slightly irregular style, giving them a distinct, hand-drawn appearance. The numbers are clearly distinguishable, and the overall impression is that of a quickly written or informal note.
DADE INTERNATIONAL
Interoffice Memorandum
FEB 1 4 1997 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: | 01/27/97 |
| Name of Product: | MMB Method for the Dimension® RxL Clinical
Chemistry System |
| FDA Classification Name: | Creatine Kinase or Isoenzyme Test System |
| Predicate Device: | Abbott Laboratories IMx® Stat CK-MB |
Device Description: The MMB Method for the Dimension® RxL Clinical Chemistry System is a one-step enzyme immunoassay based on the "sandwich" princible. Sample is incubated with chromium dioxide particles, coated with monoclonal anitbodies specific for the CKB subunit, and conjugate reagent (Bgalactosidase labeled monoclonal antibodies specific for CKMB isoenzyme). A particle-CKMB -coniugate sandwich forms during the incubation period. Unbound conjugate and analyte are removed by magnetic separation and washing. The sandwich bound ß-galactosidase is combined with a chromogenic substrate chlorophen! red-ß-d-galactopyranoside (CPRG). Hydrolysis of CPRG releases a chromophore (CPR). The color change at 577 nm is directly proportional to the concentration of CKMB in the original sample.
Intended Use: The MMB Method for the Dimension® RxL Clinical Chemistry System with the heterogeneous immunoassay module is used to quantitatively measure CKMB in human serum and plasma.
6
1
Comparison to Predicate Device:
| ltem | Dimension® RxL MMB | Imx® Stat CK-MB |
|---|---|---|
| Technology | Sandwich format | |
| monoclonal antibody | ||
| immunoassay | Sandwich format | |
| monoclonal antibody | ||
| immunoassay | ||
| Detection | Colorimetric rate | |
| measurement at 577nm | Fluorometric endpoint | |
| measurement |
Comments on Substantial
and 700nm
Equivalence: Split sample comparison between the MMB Method for the Dimension® RxL clinical chemistry system and the Abbott IMx® Stat CK-MB assay gave a correlation coefficient of 0.998, slope of 0.845, and an intercept of 0.496 ng/mL when tested with 137 clinical patient samples ranging from 0.2 -283.4 ng/mL.
Conclusion: The MMB Method for the Dimension® RxL clinical chemistry system is substantially equivalent in principle and performance to the Abbott IMx® Stat CK-MB Assay based on the split sample comparison discussed above.
City P Craft
Cathy P. Craft Regulatory Affairs and Compliance Manager Date:01/27/97
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