(71 days)
Not Found
No
The device description details a standard enzymatic reaction and spectrophotometric measurement for quantitative analysis, with no mention of AI or ML algorithms for data processing or interpretation.
No.
The device is described as an "in vitro diagnostic test" and "in vitro diagnostic product" for the measurement of creatine kinase and creatine kinase MB in serum and plasma. These measurements are used in the diagnosis and treatment of conditions, but the device itself performs a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the CKI and MBI methods are "in vitro diagnostic test[s]" used for the "diagnosis and treatment of myocardial infarction and muscle diseases".
No
The device description clearly outlines reagent cartridges and a calibrator, which are physical components used in an in vitro diagnostic test on a clinical chemistry system. This indicates the device is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use/Indications for Use: The document repeatedly states that the CKI method, the MBI method, and the CKI/MBI CAL are "in vitro diagnostic tests" or "in vitro diagnostic products."
- Measurement of Analytes in Human Samples: The intended use describes the quantitative measurement of creatine kinase and creatine kinase MB isoenzyme activity in human serum and plasma. This is a core characteristic of IVD devices.
- Clinical Purpose: The measurements are used "in the diagnosis and treatment of myocardial infarction and muscle diseases." This clearly indicates a medical purpose for the test results.
- Device Description: The device description details the reagents and processes used to perform the tests on human samples, further supporting its IVD nature.
- Calibration Product: The CKI/MBI CAL is described as an "in vitro diagnostic product for the calibration" of the CKI and MBI methods, which are themselves IVDs.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the compatibility of a transplant, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The CKI method is an in vitro diagnostic test for the quantitative measurement of creatine kinase in human serum and plasma on the Dimension® clinical chemistry system. 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.
The creatine kinase MB (MBI) method is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB isoenzyme activity in human serum and plasma on the Dimension® clinical chemistry system. 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.
The CKI/MBI CAL is an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension® clinical chemistry system.
Product codes (comma separated list FDA assigned to the subject device)
CGS, JHS, JIX
Device Description
Dimension® (CKI) Flex® Reagent Cartridge (DF38):
In a coupled enzyme reaction, the creatine kinase in patient samples catalyzes the transphosphorylation of phosphate from creatine phosphate to adenosine diphosphate (ADP) producing adenosine-triphosphate (ATP). Hexokinase (HK) phosphorylates glucose from the ATP to phosphorylate glucose. The resulting qlucose-6-phosphate is oxidized by qlucose-6-phosphate dehydrogenase (G-6-PDH) with the simultaneous reduction of nicotinamide adenine dinucleotide phosphate (NADP). The rate of formation of NADPH is directly proportional to the CK activity in the sample and is measured bichromatically at 340 and 540 nm.
Dimension® (MBI) Flex® Reagent Cartridge (DF32):
The activity of the CK-MM isoenzyme is inhibited by an antibody specific for the CK-M subunit. The activity of the B subunit of creatine kinase MB isoenzyme is not inhibited, and it is on this basis that CK-MB can be measured. In an enzyme coupled reaction, creatine kinase in patient samples catalyzes the transphosphorylation of creatine phosphate to adenosine-diphosphate (ADP), producing adenosine-triphosphate (ATP). Hexokinase (HK) uses the ATP to phosphorylate glucose. The resulting glucose-6-phosphate is oxidized by glucose-6phosphate dehydrogenase (G-6-PDH) with the simultaneous reduction of nicotinamide adenine dinucleotide phosphate (NADP) to NADPH. The rate of formation of NADPH is measured bichromatically at 340, 540 nm and is directly proportional to CK-B activity in the sample.
CKI/MBI Calibrator (DC32):
CKI/MBI CAL is a liquid, multi-analyte, human serum albumin based product containing creatine kinase (human source) and creatine kinase MB (porcine source). The kit consists of four vials per level (2 and 3) with 2.0 mL per vial. Level 1 calibrator for CKI/MBI is not included in the CKI/MBI CAL carton. Purified Water Diluent or reagent grade water is required for use as Calibrator Level 1. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k) Summary of Safety and Effectiveness for the Dimension® Creatine Kinase MB Flex® Reagent Cartridge (DF32) CKI/MBI Calibrator (DC32)
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.
| A. 510(k) Number: | K081731 |
|---|---|
| ------------------- | --------- |
B. Date of Preparation: August 21, 2008
C. Proprietary and Established Names:
Dimension® Creatine Kinase (CKI) Flex® Reagent Cartridge (DF38) Dimension® Creatine Kinase MB (MBI) Flex® Reagent Cartridge (DF32) CKI/MBI Calibrator (DC32)
D. Applicant:
Siemens Healthcare Diagnostics Inc., P.O. Box 6101, Newark, DE 19714-6101 Victor M. Carrio, Senior Manager, Regulatory Affairs Office: (302) 631-0376 Fax: (302) 631-6299
E. Regulatory Information:
Dimension® Creatine Kinase (CKI) Flex® Reagent Cartridge (DF38)
- Regulation section: 21 CFR § 862.1215 - Creatine phosphokinase/creatine kinase or isoenzymes test system
-
- Classification: Class II
-
- Product Code: CGS, Nad reduction/nadh oxidation, cpk or isoenzymes
-
- Panel: Clinical Chemistry
Dimension® Creatine Kinase MB (MBI) Flex® Reagent Cartridge (DF32)
-
- Regulation section: 21 CFR § 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system
-
- Classification: Class II
-
- Product Code: JHS, Differential rate kinetic method, cpk or isoenzymes
-
- Panel: Clinical Chemistry
CKI/MBI Calibrator (DC32)
-
- Regulation section: 21 CFR & 862.1150 Calibrator
-
- Classification: Class II
-
- Product Code: JIX, Calibrator, Multi-Analyte Mixture
-
- Panel: Clinical Chemistry
F. Predicate Devices:
Roche Diagnostic Systems Inc. CK-NAC Reagent (K834502) Roche Diagnostic Systems Inc. CK-MB Reagent (K003158) Roche Diagnostic Systems Inc. Calibrator for Automated Systems (K990460) Roche Diagnostic Systems Inc. Calibrator for Automated Systems, CKMB (K003158)
G. Device Description:
Dimension® (CKI) Flex® Reagent Cartridge (DF38)
In a coupled enzyme reaction, the creatine kinase in patient samples catalyzes the transphosphorylation of phosphate from creatine phosphate to adenosine
1
diphosphate (ADP) producing adenosine-triphosphate (ATP). Hexokinase (HK) phosphorylates glucose from the ATP to phosphorylate glucose. The resulting qlucose-6-phosphate is oxidized by qlucose-6-phosphate dehydrogenase (G-6-PDH) with the simultaneous reduction of nicotinamide adenine dinucleotide phosphate (NADP). The rate of formation of NADPH is directly proportional to the CK activity in the sample and is measured bichromatically at 340 and 540 nm.
Dimension® (MBI) Flex® Reagent Cartridge (DF32)
The activity of the CK-MM isoenzyme is inhibited by an antibody specific for the CK-M subunit. The activity of the B subunit of creatine kinase MB isoenzyme is not inhibited, and it is on this basis that CK-MB can be measured. In an enzyme coupled reaction, creatine kinase in patient samples catalyzes the transphosphorylation of creatine phosphate to adenosine-diphosphate (ADP), producing adenosine-triphosphate (ATP). Hexokinase (HK) uses the ATP to phosphorylate glucose_The resulting glucose-6-phosphate is oxidized by glucose-6phosphate dehydrogenase (G-6-PDH) with the simultaneous reduction of nicotinamide adenine dinucleotide phosphate (NADP) to NADPH. The rate of formation of NADPH is measured bichromatically at 340, 540 nm and is directly proportional to CK-B activity in the sample.
CKI/MBI Calibrator (DC32)
CKI/MBI CAL is a liquid, multi-analyte, human serum albumin based product containing creatine kinase (human source) and creatine kinase MB (porcine source). The kit consists of four vials per level (2 and3) with 2.0 mL per vial. Level 1 calibrator for CKI/MBI is not included in the CKI/MBI CAL carton. Purified Water Diluent or reagent grade water is required for use as Calibrator Level 1. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.
H. Intended Use:
Dimension® (CKI) Flex® Reagent Cartridge (DF38)
The CKI method is an in vifro diagnostic test for the quantitative measurement of creatine kinase in human serum and plasma on the Dimension® clinical chemistry system. 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.
Dimension® (MBI) Flex® Reagent Cartridge (DF32)
The creatine kinase MB (MBI) method is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB isoenzyme activity in human serum and plasma on the Dimension® clinical chemistry system. 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.
CKI/MBI Calibrator (DC32)
The CKI/MBI CAL is an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension® clinical chemistry system.
2
l. Substantial Equivalence Information:
The Dimension® (CKI) Flex® Reagent Cartridge (DF38), (MBI) Flex® Reagent Cartridge (DF32), and the CKI/MBI Calibrator (DC32) were compared to the Roche Diagnostic Systems Inc. predicate devices CK-NAC Reagent (K834502), CK-MB Reagent (K003158), Calibrator for Automated Systems (K990460), and Calibrator for Automated Systems, CKMB (K003158). A comparison of the important similarities and differences between the devices and the predicates is provided in the following tables:
| Feature | Dimension® (CKI) Flex® Reagent
Cartridge (DF38) | CK-NAC Reagent (K834502) |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | The CKI method is an in vitro
diagnostic test for the quantitative
measurement of creatine kinase in
human serum and plasma on the
Dimension® Clinical Chemistry System. | In vitro assay for the quantitative
determination of creatine kinase (CK) in
human serum and plasma on Roche
automated clinical chemistry analyzers. |
| Device
Technology
(detection) | Bichromatic rate | UV Test |
| Measuring
Range | 7 - 1000 U/L | 3-2300 U/L |
| Analytical
Sensitivity | 7 U/L | 3 U/L |
| Feature | Dimension® (MBI) Flex® Reagent
Cartridge (DF32) | CK-MB Reagent (K003158) |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | The creatine kinase MB (MBI) method
is an in vitro diagnostic test for the
quantitative measurement of creatine
kinase MB isoenzyme activity in
human serum and plasma on the
Dimension® clinical chemistry system. | Immunoinhibition assay for the
quantitative in vitro determination of the
MB isoenzyme of creatine kinase in
human serum and plasma on Roche
automated clinical chemistry analyzers. |
| Device
Technology
(detection) | Bichromatic rate | Immunological UV Assay |
| Measuring
Range | 3 - 125 U/L | 3 - 2300 U/L |
| Analytical
Sensitivity | 3 U/L | 3 U/L |
| Feature | CKI/MBI Calibrator
(DC32) | Calibrator for
Automated Systems
(K990460) | Calibrator for
Automated Systems,
CKMB (K003158) |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | The CKI/MBI CAL is an in
vitro diagnostic product
for the calibration of the
Creatine Kinase (CKI)
and Creatine Kinase MB
(MBI) methods on the
Dimension® clinical
chemistry system. | Calibrator for automated
systems (C.f.a.s.) is for
use in the calibration of
quantitative Roche
methods on Roche clinical
chemistry analyzers as
specified in the value
sheet. | C.f.a.s. (Calibrator for
automated systems) CK-
MB is for use in the
calibration of quantitative
Roche methods on
Roche clinical chemistry
analyzers as specified in
the value sheet. |
| Analyte | Creatine kinase (human | Creatine kinase (rabbit | Creatine kinase-MM |
3
| | source) and creatine
kinase-MB (porcine
source) | muscle) | (human source) and CK-
BB (porcine brain) |
|--------|-------------------------------------------------------|-------------|----------------------------------------------|
| Matrix | Human serum albumin | Human serum | Human serum |
| Form | Liquid | Lyophilized | Lyophilized |
| Levels | CKI - Three levels
MBI - Five levels | Two levels | Two levels |
J. Conclusion:
The Dimension® (CKI) Flex® Reagent Cartridge (DF38), (MBI) Flex® Reagent Cartridge (DF32), and the CKI/MBI Calibrator (DC32) are substantially equivalent to the Roche Diagnostic Systems Inc. predicate devices CK-NAC Reagent (K834502), CK-MB Reagent (K003158), Calibrator for Automated Systems (K990460), and Calibrator for Automated Systems, CKMB (K003158). Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Siemens Healthcare Diagnostics Inc. c/o Mr. Victor M. Carrio P.O. Box 6101, Mailbox 514 Newark, DE 19714-6101
AUG 2 9 2008
Re: K081731
Trade/Device Name: Dimension® Creatine Kinase (CKI) Flex® Reagent Cartridge (DF38), Dimension® Creatine Kinase MB (MBI) Flex® Reagent Cartridge (DF32) CK/MBI Calibrator (DC32)
Regulation Number: 21 CFR§ 862.1215
Regulation Name: Creatine Phosphokinase/Creatine Kinase or Isoenzymes Test System Regulatory Class: Class II Product Code: CGS, JHS, JIX Dated: June 17, 2008 Received: June 19, 2008
Dear Mr. Carrio:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and this, permitte your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please nother the regulation entitled, "Misbranding by reference to premarket notification", (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollit the number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Jean M. Cooper, M.S., D.V.M.
Yéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K081731
Device Name:
Dimension® (MBI) Flex® Reagent Cartridge (DF32)
Indication For Use:
The creatine kinase MB (MBI) method is an in vitro diagnostic test for the quantitative measurement of creatine kinase MB isoenzyme activity in human serum and plasma on the Dimension® clinical chemistry system. 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.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)(081731
7
Indications for Use
510(k) Number (if known): K081731
Device Name:
Dimension® (CKI) Flex® Reagent Cartridge (DF38)
Indication For Use:
The CKI method is an in vitro diagnostic test for the quantitative measurement of creatine kinase in human serum and plasma on the Dimension® clinical chemistry system. 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.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)to81731
8
Indications for Use
510(k) Number (if known): K081731
Device Name:
Dimension® CKI/MBI Calibrator (DC32)
Indication For Use:
The CKI/MBI CAL is an in vitro diagnostic product for the calibration of the Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods on the Dimension® clinical chemistry system.
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Distion Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081731