(18 days)
Not Known
Please provide the full document to accurately identify the Reference Device(s) K/DEN numbers. The current input explicitly states "Reference Device(s) Not Found".
No
The description details a chemiluminescent immunoassay for measuring CK-MB levels, which is a standard laboratory technique and does not mention any AI or ML components.
No
The device is used for the quantitative determination of CK-MB in serum or plasma, which is a diagnostic function, not a therapeutic one.
Yes
This device is intended for the "quantitative determination of CK-MB (CK-2) in serum or plasma," which is a diagnostic measurement used to identify and monitor medical conditions related to cardiac health.
No
The device description clearly outlines a chemical assay involving antibodies, paramagnetic particles, and a chemilumometric process, indicating a hardware-based laboratory test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of CK-MB (CK-2) in serum or plasma". Serum and plasma are biological specimens taken from the human body.
- Device Description: The description details an "assay" that uses antibodies to measure a substance (CK-MB) in these biological specimens. This is a hallmark of in vitro diagnostic tests.
- Performance Studies: The performance studies describe accuracy and precision in measuring CK-MB in samples, further confirming its use for analyzing biological materials.
- Predicate Device: The mention of a "predicate device" which is also an "Enzyme Immunoassay" strongly suggests that this device falls under the same regulatory category, which for this type of test is IVD.
The device is designed to be used in vitro (outside the body) to analyze biological samples for diagnostic purposes (determining the amount of CK-MB, which is relevant for diagnosing certain medical conditions).
N/A
Intended Use / Indications for Use
The intended use of ACS CKMB II is for the quantitative determination of CK-MB (CK-2) in serum or plasma using the Ciba Corning Automated Chemiluminescence Systems.
Product codes
Not Found
Device Description
The Ciba Corning ACS CKMB II assay is a two-site chemilumometric (sandwhich) assay. which uses constant amounts of two antibodies. The first antibody or Lite Reagent is a monoclonal mouse anti-CK-MB antibody labeled with acridinium ester. The second antibody or solid phase is a monoclonal mouse anti-CK-BB antibody covalently coupled to paramagnetic particles. A direct relationship exists between the CK-MB in a sample and the relative light units (RLUs) detected by the ACS:180 systems. The assay is unaffected by increased levels of other CK isoenzymes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The ACS CKMB II assay measures CK-MB concentrations up to 300.0 ng/mL with a minimum detectable concentration of 0.18 ng/mL.
For 1744 samples in the range of 0.0 to 280.0 ng/mL, the correlation between the ACS CKMB Il assay and the FEIA reference method assay is described by the equation: ACS CKMB II = 1.01 (FEIA reference method) + 0.24. Correlation coefficient (r) = 0.96.
Total precision (Total % CV) ranged form 3.0 to 3.5.
Key Metrics
Not Found
Predicate Device(s)
Not Known
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
JIN 21 1996
Summary of Safety and Effectiveness
As required by 21 CFR 807.92, the following 510(k) Summary is provided:
1. Submitter Information
| Contact person: | Thomas F. Flynn |
|---|---|
| Address: | Ciba Corning Diagnostics Corp. |
| 63 North Street | |
| Medfield, MA 02052 | |
| Phone: | |
| FAX | |
| e-mail: | 508 359-3877 |
| 508 359-3885 | |
| thomas.flynn@cibadiag.com |
Date Summary Prepared: May 30, 1996
2. Device Information
| Proprietary Name: | ACS CKMB II Immunoassay |
|---|---|
| Common Name: | CK-MB Immunoassay |
| Classification Name: | Class II, Creatine phosphokinase/creatine kinase or Isoenzymes test system, 21 CFR 862.1215 |
3. Predicate Device Information
| Name: | Baxter Stratus CK-MB Fluorometric Enzyme Immunoassay |
|---|---|
| Manufacturer: | Baxter |
| 510(k) Number: | Not Known |
4. Device Description
The Ciba Corning ACS CKMB II assay is a two-site chemilumometric (sandwhich) assay. which uses constant amounts of two antibodies. The first antibody or Lite Reagent is a monoclonal mouse anti-CK-MB antibody labeled with acridinium ester. The second antibody or solid phase is a monoclonal mouse anti-CK-BB antibody covalently coupled to paramagnetic particles. A direct relationship exists between the CK-MB in a sample and the relative light units (RLUs) detected by the ACS:180 systems. The assay is unaffected by increased levels of other CK isoenzymes.
5. Statement of Intended Use
The intended use of ACS CKMB II is for the quantitative determination of CK-MB (CK-2) in serum or plasma using the Ciba Corning Automated Chemiluminescence Systems.
1
6. Summary of Technological Characteristics
The Ciba Corning CKMB II assay is a non-competitive chemiluminescence assay.
7. Performance Data
Sensitivity
ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
The ACS CKMB II assay measures CK-MB concentrations up to 300.0 ng/mL with a minimum detectable concentration of 0.18 ng/mL.
Accuracy
For 1744 samples in the range of 0.0 to 280.0 ng/mL, the correlation between the ACS CKMB Il assay and the FEIA reference method assay is described by the equation:
ACS CKMB II = 1.01 (FEIA reference method) + 0.24
Correlation coefficient (r) = 0.96
Precision
Total precision (Total % CV) ranged form 3.0 to 3.5.