(61 days)
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No
The description focuses on automated laboratory procedures and fluorescence measurement, with no mention of AI or ML terms or concepts.
No
The device is described as a fluorometric analyzer and an in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase. It is used in the diagnosis and treatment of myocardial infarction and muscle diseases, but it does not directly treat or alleviate a disease, injury, or disability. Its purpose is to provide diagnostic information.
Yes
The "Intended Use / Indications for Use" section explicitly states that the measurements obtained from the device "are used in the diagnosis and treatment of myocardial infarction and muscle diseases." This directly indicates its diagnostic purpose.
No
The device description clearly describes a benchtop instrument (hardware) that processes in vitro diagnostic tests using physical components like pipetting, incubation, and fluorescence measurement. The software is part of this larger hardware system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the measurements of CKMB are used in the "diagnosis and treatment of myocardial infarction and muscle diseases". This is a key characteristic of an IVD, as it's used to provide information for diagnostic purposes.
- Device Description: The description of the CKMB TestPak clearly states it is an "in vitro diagnostic test".
- Functionality: The device analyzes a biological sample (heparinized plasma) in vitro (outside the body) to measure a specific analyte (CKMB). This is the fundamental definition of an IVD.
N/A
Intended Use / Indications for Use
Measurements of CKMB are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. The fluorometric analyzer is intended to duplicate manual analytical procedures by performing automatically various steps, such as pipetting, incubation and measuring fluorescence.
Product codes (comma separated list FDA assigned to the subject device)
JHX, KHO
Device Description
The Stratus® CS STAT fluorometric analyzer is a benchtop instrument capable of processing up to four in vitro diagnostic tests per sample. An operator of the analyzer introduces a specimen collection tube filled with whole blood into the instrument, along with the appropriate TestPaks for processing. The instrument transfers and spins an aliquot of the sample, delivers the spun plasma and other self-contained reagents to the reaction area of the TestPak, reads the reaction rate via front surface fluorescence and prints out quantitative test results.
The CKMB TestPak used on the Stratus® CS STAT fluorometric analyzer is an in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase in heparinized plasma.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A split sample comparison study was conducted between the two systems with the following results:
n: 215
Slope: 0.97
Intercept: 0.65
Correlation Coefficient: 0.988
Range of Samples: 0.0 - 123.9 ng/mL
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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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
MAY 26 1998
SECTION A
Summary of Safety and Effectiveness
0000003
1
DADE BEHRING
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
Stratus® CS STAT fluorometric analyzer Stratus® CS CKMB TestPak
Summary of Safety and Effectiveness
The Stratus® CS STAT fluorometric analyzer is a benchtop instrument capable of processing up to four in vitro diagnostic tests per sample. An operator of the analyzer introduces a specimen collection tube filled with whole blood into the instrument, along with the appropriate TestPaks for processing. The instrument transfers and spins an aliquot of the sample, delivers the spun plasma and other self-contained reagents to the reaction area of the TestPak, reads the reaction rate via front surface fluorescence and prints out quantitative test results.
The CKMB TestPak used on the Stratus® CS STAT fluorometric analyzer is an in vitro diagnostic test for the measurement of the MB isoenzyme of creatine kinase in heparinized plasma.
The Stratus® CS STAT fluorometric analyzer is substantially equivalent to the Dade Stratus® fluorometric analyzer, which was cleared by the FDA through the 510(k) process. The CKMB assay performed by the CKMB TestPak is substantially equivalent to the CKMB assay performed on the Dade Stratus® analyzer, which was also cleared by the FDA through the 510(k) process. Both methodologies have the same intended uses and are processed on automated systems using similar detection systems for the determination of CKMB.
A split sample comparison study was conducted between the two systems with the following results:
| n | Slope | Intercept | Correlation
Coefficient | Range of
Samples |
|-----|-------|-----------|----------------------------|---------------------|
| 215 | 0.97 | 0.65 | 0.988 | 0.0 - 123.9 |
0.0 - 123.9 ng/mL
Carolyn K. George
Carolyn K. George Regulatory Affairs and Compliance Manager
March 24, 1998
Date
2
MAY 2 6 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Carolyn K. George Regulatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714
Re : K981099 Stratus® CS STAT Fluorometric Analyzer and Stratus® CS CKMB TestPak Requlatory Class: II Product Code: JHX, KHO March 24, 1998 Dated: Received: March 26, 1998
Dear Ms. George:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Bitman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
4
Indications Statement
Device Name: Stratus® CS CKMB TestPak
Indications for Use: Measurements of CKMB are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.
Device Name: Stratus® CS STAT fluorometric analyzer
Indications for Use: The fluorometric analyzer is intended to duplicate manual analytical procedures by performing automatically various steps, such as pipetting, incubation and measuring fluorescence.
Evelyn K. Yenge
Carolyn K. George Regulatory Affairs and Compliance Manager
March 24, 1998
Date
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Clinical 510(k) Number
K98/099
510(k) Number
Division Sign-Off Office of Device Evaluation
prescription use
0000000