(28 days)
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No
The summary describes a chemical reagent and its use with laboratory analyzers for measuring creatinine. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a reagent for measuring creatinine, which is used in the diagnosis and treatment of renal diseases, but it is not a therapeutic device itself. It is an in vitro diagnostic (IVD) device.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "Creatinine measurements are used in the diagnosis and treatment of renal diseases." Since this device determines creatinine concentration, it directly aids in diagnosis.
No
The device is a reagent kit, which is a chemical substance used in a laboratory test. The description clearly states it is a "reagent kit" and mentions "cartridges," indicating a physical component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the quantitative determination of creatinine concentration in human serum, plasma, or urine. This is a measurement performed in vitro (outside the body) on biological samples.
- Diagnosis and Treatment: The intended use also mentions that these measurements are used in the diagnosis and treatment of renal diseases, monitoring renal dialysis, and as a calculation basis for other urine analytes. This directly aligns with the purpose of IVDs, which are used to provide information for diagnostic purposes.
- Device Description: The description details a reagent used to measure a substance in biological samples using an enzymatic method, which is a common technique in IVD testing.
- Predicate Device: The mention of a predicate device with a K number (K091742) and the name "SYNCHRON Systems Enzymatic Creatinine (CR-E) Reagent" strongly indicates that this device is being submitted for regulatory review as an IVD, likely through the 510(k) pathway. Predicate devices are used to demonstrate substantial equivalence for new IVDs.
N/A
Intended Use / Indications for Use
CR-E reagent, when used in conjunction with SYNCHRON® System(s), UniCel® DxC System(s) and SYNCHRON® Systems AQUA CAL 1 and 2 and SYNCHRON CX Calibrator Level 1 and 2, is intended for the quantitative determination of creatinine (CR-E) concentration in human serum, plasma or urine (urine is not available on the
SYNCHRON CX® PRO Systems).
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.
Product codes (comma separated list FDA assigned to the subject device)
JFY
Device Description
CR-E reagent is used to measure the creatinine concentration by an enzymatic method. This enzymatic creatinine method utilizes a multi-step approach ending with a photometric end-point reaction.
The SYNCHRON Enzymatic Creatinine (CR-E) Reagent is designed for optimal performance on the SYNCHRON LX, UniCel® DxC 600/800, and SYNCHRON CX® PRO Clinical Systems. The reagent kit contains two 200-test cartridges that are packaged separately from the associated calibrator.
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)
Performance data from validation testing supports equivalency.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The modification to the SYNCHRON Systems CR-E assay involves extending the Limit of Detection (Beckman Coulter uses the term Analytical Sensitivity to characterize Limit of Detection in its product labeling) to 0.1 mg/dL for serum samples. The Limit of Detection for urine samples remains unchanged.
The current claimed Analytical Sensitivity for creatinine determination by the CR-E assay (cleared under FDA 510(k) Number K091742) is 0.2 mg/dL for serum and 10 mg/dL for urine (on SYNCHRON LX/UniCel DxC Clinical Systems only).
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.
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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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§ 862.1225 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.
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Summary of Safety & Effectiveness SYNCHRON® Systems Enzymatic Creatinine (CR-E) Reagent
093458
1.0 Submitted By:
Marine Boyajian Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-110 Brea, California 92822-8000 Telephone: (714) 961-6536 FAX: (714) 961-4234
DEC - 4 2009
2.0 Date Submitted:
November 04, 2009
3.0 Device Name(s):
Proprietary Names 3.1
- SYNCHRON® Systems Enzymatic Creatinine (CR-E) Reagent
- 3.2 Classification Name Enzymatic Method Creatinine (21 CFR § 862.1225)
4.0 Predicate Device:
The SYNCHRON Systems Enzymatic Creatinine (CR-E) Reagent claims substantial equivalence to the Beckman Coulter SYNCHRON Systems Enzymatic Creatinine (CR-E) reagent currently in commercial distribution, FDA 510(k) Number K091742.
| Candidate(s) | Predicate | Manufacturer | Docket
Number |
|------------------------------------------------------------|------------------------------------------------------------|-------------------------|------------------|
| SYNCHRON Systems
Enzymatic Creatinine (CR-E)
Reagent | SYNCHRON Systems
Enzymatic Creatinine (CR-E)
Reagent | Beckman
Coulter, Inc | K091742 |
5.0 Description:
CR-E reagent is used to measure the creatinine concentration by an enzymatic method. This enzymatic creatinine method utilizes a multi-step approach ending with a photometric end-point reaction.
The SYNCHRON Enzymatic Creatinine (CR-E) Reagent is designed for optimal performance on the SYNCHRON LX, UniCel® DxC 600/800, and SYNCHRON CX® PRO Clinical Systems. The reagent kit contains two 200-test cartridges that are packaged separately from the associated calibrator.
6.0 Intended Use:
CR-E reagent, when used in conjunction with SYNCHRON® System(s), UniCel® DxC System(s) and SYNCHRON® Systems AQUA CAL 1 and 2 and SYNCHRON CX Calibrator Level 1 and 2, is intended for the quantitative determination of creatinine (CR-E) concentration in human serum, plasma or urine (urine is not available on the
SYNCHRON CX® PRO Systems).
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.
1
Comparison to Predicate(s): 7.0 (Description of the Modification to the Legally Marketed Device)
The modification to the SYNCHRON Systems CR-E assay involves extending the Limit of Detection (Beckman Coulter uses the term Analytical Sensitivity to characterize Limit of Detection in its product labeling) to 0.1 mg/dL for serum samples. The Limit of Detection for urine samples remains unchanged.
The current claimed Analytical Sensitivity for creatinine determination by the CR-E assay (cleared under FDA 510(k) Number K091742) is 0.2 mg/dL for serum and 10 mg/dL for urine (on SYNCHRON LX/UniCel DxC Clinical Systems only).
8.0 Summary of Performance Data:
Performance data from validation testing supports equivalency.
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Image /page/2/Picture/0 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Beckman Coulter, Inc. c/o Ms. Marine Boyajian Senior Regulatory Affairs Specialist 200 S. Kraemer Blvd., M/S W-110 Brea, CA 92822-8000
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Image /page/2/Picture/4 description: The image shows the letters 'OCC' followed by the number '1' and then the number '2000'. The text and numbers are in bold black font. The background is white.
Re: K093458
Trade Name: SYNCHRON Systems Enzymatic Creatinine (CR-E) Reagent Regulation Number: 21 CFR §862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Codes: JFY Dated: November 4, 2009 Received: November 6, 2009
Dear Ms. Boyajian:
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indication for Use
8093458 510(k) Number (if known):
Device Name: SYNCHRON® Systems Enzymatic Creatinine (CR-E) Reagent
Indication For Use:
CR-E reagent, when used in conjunction with SYNCHRON® Systems, UniCel® DxC Systems and SYNCHRON® Systems AQUA CAL 1 and 2 and SYNCHRON CX® Calibrator Level 1 and 2, is intended for the quantitative determination of creatinine (CR-E) concentration in human serum,
plasma or urine (urine is not available on the SYNCHRON CX PRO Systems).
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.
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)
signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K093458