(54 days)
Not Found
No
The device description details a standard immunoassay based on chemical reactions and electrochemiluminescence detection. There is no mention of AI or ML in the device description, intended use, or performance studies. The results are determined via a calibration curve, which is a traditional method, not indicative of AI/ML.
No
This device is an immunoassay for in vitro quantitative determination, used for diagnosis and treatment of conditions rather than direct therapy.
Yes
This device is intended to measure CK-MB levels, which are explicitly stated as being "used in the diagnosis and treatment of myocardial infarction and muscle diseases." This direct link to diagnosis makes it a diagnostic device.
No
The device description details a complex immunoassay process involving chemical reactions, microparticles, magnetic capture, and electrochemiluminescence detection, which are all hardware-based components and processes.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase (CK-MB) in human serum and plasma." The phrase "in vitro" is a key indicator of an IVD.
- Sample Type: The device analyzes "human serum and plasma," which are biological samples taken from the body but tested outside of it.
- Purpose: The test is used "in the diagnosis and treatment of myocardial infarction and muscle diseases," which is a diagnostic purpose.
- Device Description: The description details a laboratory-based immunoassay process involving chemical reactions and detection methods, typical of IVD devices.
The provided information clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of the MB isoenzyme of creatine kinase (CK-MB) in human serum and plasma.
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 kinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy
Product codes
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Device Description
The Elecsys® CK-MB test principle is based on a two-step sandwich with Streptavidin microparticles and electrochemiluminescence detection.
Total duration of the assay: 9 minutes
- 1st incubation: 15 µl of sample, a biotinylated monoclonal CK-MB-specific antibody and a monoclonal CK-MB-specific antibody labeled with a ruthenium complex react to form a sandwich complex
- 2nd incubation: after the addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin.
- The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier.
- Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar code.
Mentions image processing
Not Found
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
Precision (NCCLS (modif.)):
- HS1: Sample N=60, Mean=5.40, wi/in run %CV=3.0, total run %CV=5.1
- HS2: Sample N=60, Mean=26.8, wi/in run %CV=3.5, total run %CV=4.1
- HS3: Sample N=60, Mean=107.7, wi/in run %CV=3.7, total run %CV=4.4
- CCI: Sample N=60, Mean=4.72, wi/in run %CV=3.9, total run %CV=4.6
- CCII: Sample N=60, Mean=65.5, wi/in run %CV=3.5, total run %CV=4.4
Sensitivity: Lower Detection Limit: 0.150 ng CK-MB / ml
Assay Range (LDL to highest standard): 0.100 - 500.0 ng/ml
Method Comparison:
- vs. Abbott IMx CK-MB (Least Squares): N = 95, y = 0.9735 + 1.0224x, r = 0.996
- vs. Abbott IMx CK-MB (Passing/Bablok): N = 95, y = 0.2095 + 0.9465x, r = 0.996
Interfering substances (No interference at):
- Hemoglobin: 1.0 g/dl
- Lipemia: 1,500 mg/dl
- Bilirubin: 28 mg/dl
Specificity (% Cross-reactivity):
- CK-BB: 0.0600 (1,000 ng/ml), 0.1600 (2,500 ng/ml), 0.0020 (5,000 ng/ml), 0.0000 (10,000 ng/ml)
- CK-MM: 0.0500 (1,000 ng/ml), 0.0000 (2,500 ng/ml), 0.0000 (5,000 ng/ml), 0.0030 (10,000 ng/ml)
Key Metrics
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Predicate Device(s)
Abbott IMx CK-MB (K931172)
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
દ્વારા નિર્માન કરતાં છે. આ ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપા C
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JUN 1 | 1996 510(k) Summary
,
مست
مرمسسيد
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| 1) Submitter name, address, contact | Boehringer Mannheim Corporation |
| 9115 Hague Rd. | |
| Indianapolis, IN 46250 | |
| (317) 845-2000 |
Contact Person: LeeAnn Chambers
Date Prepared: April 12, 1996 |
| 2) Device name | Proprietary name: Elecsys® CK-MB
Common name: creatine kinase test |
| 3) Predicate device | We claim substantial equivalence to the Abbott IMx CK-MB (K931172) |
| 4) Device Description | The Elecsys® CK-MB test principle is based on a two-step sandwich with Streptavidin microparticles and electrochemiluminescence detection.
Total duration of the assay: 9 minutes 1st incubation: 15 µl of sample, a biotinylated monoclonal CK-MB-specific antibody and a monoclonal CK-MB-specific antibody labeled with a ruthenium complex react to form a sandwich complex2nd incubation: after the addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin. |
| | Continued on next page |
1
510(k) Summary, Continued
्र कमामी
बाहरी
ﺳﺴﺴ
سمسس
| 4) Device
Description,
(cont.) | • The reaction mixture is aspirated into the measuring cell where the
microparticles are magnetically captured onto the surface of the electrode.
Unbound substances are then removed with ProCell. Application of a
voltage to the electrode then induces chemiluminescent emission which is
measured by a photomultiplier.
• Results are determined via a calibration curve which is instrument-
specifically generated by 2-point calibration and a master curve provided
via the reagent bar code. | Feature | Elecsys® CK-MB | IMx CK-MB |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|---------------------------------------------------------------------------|------------------------------------------------------------------------|
| 5) Intended use | Immunoassay for the in vitro quantitative determination of the MB isoenzyme
of creatine kinase (CK-MB) in human serum and plasma. | Reaction test
principle | streptavidin microparticles and
electrochemiluminescence
technology | antibody coated microparticles
and enzyme immunoassay
technology |
| | 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 kinase and its isoenzymes are
used in the diagnosis and treatment of myocardial infarction and muscle
diseases such as progressive, Duchenne-type muscular dystrophy | Instrument
required | Elecsys 2010 analyzer | Abbott IMx System |
| 6) Comparison
to predicate
device | The Boehringer Mannheim Elecsys® CK-MB is substantially equivalent to
other products in commercial distribution intended for similar use. Most
notably it is substantially equivalent to the currently marketed Abbott IMx
CK-MB. | Sample volume | 15 μl | 150 μl |
| | The following table compares the Elecsys® CK-MB with the predicate
device, Abbott IMx CK-MB. Specific data on the performance of the test
have been incorporated into the draft labeling in section 5. Labeling for the
predicate device is provided in section 6. | | | |
| | Similarities:
• Intended use: immunoassay for the in vitro quantitative determination of
the MB isoenzyme of creatine kinase (CK-MB)
• Sample type - human serum or plasma
• Two step sandwich immunoassay
• Mouse monoclonal antibody utilized to capture the CK-MB analyte | | | |
| | Continued on next page | | | |
2
510(k) Summary, Continued
- Comparison to predicate Differences: device, (cont.)
ﺴﺴﺴﻪ
Performance Characteristics:
| Feature | Elecsys® CK-MB | IMx CK-MB | ||||||
|---|---|---|---|---|---|---|---|---|
| NCCLS | ||||||||
| (modif.) | ||||||||
| Precision | HS1 | HS2 | HS3 | CCI | CCII | 1 | 2 | 3 |
| Sample | ||||||||
| N | 60 | 60 | 60 | 60 | 60 | 48 | 48 | 48 |
| 5.40 | 26.8 | 107.7 | 4.72 | 65.5 | 5.0 | 20.1 | 116.5 | |
| Mean | 3.0 | 3.5 | 3.7 | 3.9 | 3.5 | 4.5 | 4.2 | 3.0 |
| wi/in run %CV | ||||||||
| total run %CV | 5.1 | 4.1 | 4.4 | 4.6 | 4.4 | 6.3 | 6.1 | 5.4 |
| Sensitivity | Lower Detection Limit: | |||||||
| 0.150 ng CK-MB / ml | Lower Detection Limit: | |||||||
| 0.7 ng CK-MB / ml | ||||||||
| Assay Range | ||||||||
| (LDL to highest | ||||||||
| standard) | 0.100 - 500.0 ng/ml | 0.7 - 300 ng/ml | ||||||
| Method | ||||||||
| Comparison | vs. Abbott IMx CK-MB (Least Squares) | |||||||
| N = 95 | ||||||||
| y = 0.9735 + 1.0224x | ||||||||
| r = 0.996 |
(Passing/Bablok)
N = 95
y = 0.2095 + 0.9465x
r = 0.996 | | | | | vs. Hybritech Tandem®-E CK-MB
N = 693
y = -0.52 + 0.82x
r = 0.975 | | |
Continued on next page
3
510(k) Summary, Continued
6) Comparison Performance Characteristics (cont.): to predicate
device, (cont.)
ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
| Interfering
| substances: | No interference at: | No interference at: |
|---|---|---|
| Hemoglobin | 1.0 g/dl | 50 mg/dl |
| Lipemia | 1,500 mg/dl | 750 mg/dl |
| Bilirubin | 28 mg/dl | 1,000 mg/dl |
| Specificity | % Cross-reactivity | % Cross-reactivity |
| CK-BB | 0.0600 (1,000 ng/ml) | 0.0005 (10,000 ng/ml) |
| 0.1600 (2,500 ng/ml) | ||
| 0.0020 (5,000 ng/ml) | ||
| 0.0000 (10,000 ng/ml) | ||
| CK-MM | 0.0500 (1,000 ng/ml) | 0.012 (5,000 ng/ml) |
| 0.0000 (2,500 ng/ml) | ||
| 0.0000 (5,000 ng/ml) | ||
| 0.0030 (10,000 ng/ml) |