(65 days)
Not Found
No
The summary describes a standard in vitro diagnostic test using chemical reagents and a clinical chemistry system. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is described as an in vitro diagnostic test for measuring creatinine, which is used for diagnosis and monitoring, not for providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension® clinical chemistry system." It also mentions that "Creatinine measurements are used in the diagnosis and treatment of renal diseases." The "Device Description" also refers to it as a "prepackaged in-vitro diagnostic test method."
No
The device is an in vitro diagnostic test method that includes physical reagents and is designed to be used on a specific hardware system (Dimension® Clinical Chemistry System). It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states "The ECRE method is an in vitro diagnostic test..." and describes its use for measuring creatinine in human serum, plasma, and urine for diagnostic and treatment purposes related to renal diseases.
- Device Description: Describes the device as a "prepackaged in-vitro diagnostic test method" and lists the reagents used for the test.
Both sections clearly identify the device as an in vitro diagnostic product.
N/A
Intended Use / Indications for Use
The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension® clinical chemistry system. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes.
Product codes (comma separated list FDA assigned to the subject device)
JFY
Device Description
The Dimension® ECRE Flex® reagent cartridge is a prepackaged in-vitro diagnostic test method that is specifically designed to be used on the Dade Behring Dimension® Clinical Chemistry System. The reagents contained in the Dimension® ECRE Flex® reagent cartridge are: Reagent 1 - TAPS buffer, creatinase, sarcosine oxidase, HTIB; Reagent 2 - TAPS buffer, creatininase, horseradish peroxidase, 4-aminophenazon, and potassium hexacyanoferrate (II).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.
0
K073055
510(k) Summary of Safety and Effectiveness for the Dimension® Enzymatic Creatinine (ECRE) Flex® Reagent Cartridge (DF270)
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:
B. Date of Preparation: October 24, 2007
JAN - 3 2008
C. Proprietary and Established Names:
Dimension® Enzymatic Creatinine (ECRE) Flex® Reagent Cartridge (DF270)
- D. Applicant: Dade Behring Inc., P.O. Box 6101, Newark, DE 19714-6101 Victor M. Carrio, Regulatory Affairs and Compliance Manager Office: (302) 631-0376 Fax: (302) 631-6299
E. Regulatory Information:
-
- Regulation section: 21 CFR § 862.1225 Creatinine Test System
-
- Classification: Class II
-
- Product Code: JFY Enzymatic Method, Creatinine
-
- Panel: Clinical Chemistry
F. Predicate Device:
The Dimension® ECRE Flex® reagent cartridge is substantially equivalent to Roche's Creatinine Plus Reagent (K003261).
G. Device Description:
The Dimension® ECRE Flex® reagent cartridge is a prepackaged in-vitro diagnostic test method that is specifically designed to be used on the Dade Behring Dimension® Clinical Chemistry System. The reagents contained in the Dimension® ECRE Flex® reagent cartridge are: Reagent 1 - TAPS buffer, creatinase, sarcosine oxidase, HTIB; Reagent 2 - TAPS buffer, creatininase, horseradish peroxidase, 4-aminophenazon, and potassium hexacyanoferrate (II).
1
- H. Intended Use: The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in human scrum, plasma, and urine on the Dimension® clinical chemistry system. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes.
I. Substantial Equivalence Information:
The Dimension® ECRE Flex® reagent cartridge and the predicate, Roche Creatinine Plus reagent were compared. A comparison of the important similarities and differences between the device and the predicates is provided in the following table:
| Feature | Dimension® ECRE Flex®
reagent cartridge | Creatinine Plus Reagent
(K003261) |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The ECRE method is an in vitro
diagnostic test for the quantitative
measurement of creatinine in human
serum, plasma, and urine on the
Dimension® clinical chemistry system.
Creatinine measurements are used in
the diagnosis and treatment of renal
diseases, in monitoring renal dialysis,
and as a calculation basis for other
urine analytes. | Enzymatic in vitro assay for the direct
quantitative determination of creatinine in
human serum, plasma and urine using
Roche clinical chemistry analyzers. |
| Sample Type | Plasma, serum, and urine. | Human serum, plasma and urine. |
| Measuring
Range | 0.03 -20.00 mg/dL | 0.03 - 30 mg/dL |
| Sample Size | 6 [Mu]L | 6 [Mu]L |
| Measurement | Bichromatic end point | Bichromatic end point |
J. Conclusion:
The Dimension® ECRE Flex® reagent cartridge is substantially equivalent to Roche's Creatinine Plus Reagent (K003261). Comparative testing described in the protocol included in this submission demonstrates substantial equivalent performance.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three stripes forming its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN - 3 2008
Dade Behring, Inc. Glasgow Business Community c/o Mr. Victor Carrio RA/QS Compliance Manager P.O. Box 6101, M/S 514 Newark, DE 19714-6101
Re: K073055
Trade/Device Name: Dimension Enzymatic Creatinine (ECRE) Flex Reagent Cartridge, Model DF270 Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system. Regulatory Class: Class II Product Code: JFY Dated: October 29, 2007 Received: October 30, 2007
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).
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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 thus, permits 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 note 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 toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Jean M. Cooper, M.S., D.V.M.
Yean 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
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Indications For Use Statement
510(k) Number (if known):
Device Name:
Dimension® ECRE Flex® Reagent Cartridge (DF270)
Indications for Use:
The ECRE method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension® clinical chemistry system. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for other urine analytes.
Sean Coope
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
51000 K073055
Prescription Use X (Per 21 CFR 801 Subpart D)
mil hill bit hill bet her me ans met and and and and ann ann ages and any and
AND/OR
Over-the-counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of -In Vitro Diagnostic Devices (OIVD)