(25 days)
Not Found
No
The device description details a chemical reaction-based measurement method (Jaffe rate method) and does not mention any computational or algorithmic processes indicative of AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
This device is a calibrator and reagent used for the quantitative determination of Creatinine, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section states that the CRE3 reagent, in conjunction with the SYNCHRON CX Delta Systems and Calibrators, is "intended for the quantitative determination of Creatinine (CRE3) in human serum, plasma or urine." This quantitative determination of a substance in bodily fluids for diagnostic purposes makes it a diagnostic device.
No
The device description clearly describes a "SYNCHRON CX Delta System" which is a physical instrument that performs chemical analysis using reagents and takes absorbance readings. It also describes physical calibrators and reagents. This is a hardware-based system, not software-only.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the quantitative determination of Creatinine (CRE3) in human serum, plasma or urine. This is a classic example of an in vitro diagnostic test, as it analyzes biological samples taken from the human body outside of the body itself.
- Device Description: The description details a system (SYNCHRON CX Delta System) and reagents (CRE3 reagent, SYNCHRON CX Calibrators) used to perform this analysis. This aligns with the components of an IVD system.
- Method: The description mentions the "Jaffe rate method," which is a common laboratory technique for measuring creatinine.
- Calibrators: The use of calibrators (SYNCHRON CX Calibrators 1, 2, and 3) is essential for quantitative IVD tests to ensure accurate measurements.
- Predicate Device: The mention of a predicate device (K950958; Beckman Coulter SYNCHRON CX Delta Clinical System) further supports that this is a medical device, and given the intended use, specifically an IVD.
The fact that it does not mention image processing, AI, DNN, or ML, and the input imaging modality and anatomical site are not applicable, are all consistent with a typical chemical analyzer IVD.
N/A
Intended Use / Indications for Use
Beckman Coulter SYNCHRON CX Calibrators 1, 2, and 3 are to be used for calibrating SYNCHRON CX Delta, CX® CE, and CX PRO Systems only.
CRE3 reagent, in conjunction with SYNCHRON CX® Delta Systems and SYNCHRON CX® Calibrators 1, 2 and 3 is intended for the quantitative determination of Creatinine (CRE3) in human serum, plasma or 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.
Product codes
CGX, JIX
Device Description
The SYNCHRON CX Delta System determines creatinine concentration by means of the Jaffe rate method. A precise volume of sample is injected into the reaction cup with CRE3 reagent containing picric acid. Absorbance readings are taken at 520 nm between 19 to 25 seconds after sample introduction. The SYNCHRON CX Delta System utilizes a two level calibrator for the creatinine test. SYNCHRON CX Calibrator is designed for optimal performance on the SYNCHRON CX Delta Clinical Systems. CX Calibrator is an aqueous based calibrator made by New England Reagent Laboratory (NERL) to Beckman Coulter specifications, This product is tested during manufacturing using standards traceable to National Institute of Standard and Technology (NIST) reference materials. The creatinine concentrations are established based on addition of weighed-in specific quantities of creatinine to achieve the appropriate level of each calibrator. Each calibrator level is packaged individually in 25 mL bottles, 6 to a package.
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
Performance data from validation testing supports equivalency.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Summary
JUN - 1 2007
1.0 Submitted Bv:
Tara M. Viviani Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-110 Brea, CA 92822-8000 Telephone: (714) 961-3626 FAX: (714) 961-4123
2.0 Date Submitted
May 4, 2007
3.0 Device Name(s):
- 3.1 Proprietary Names
SYNCHRON® CX Delta Clinical System SYNCHRON® CX Calibrator 1, 2 &3
3.2 Classification Names
Creatinine test system (21 CFR § 862.1225) Calibrator, Multi-Analyte Mixutre (21 CFR § 862.1150)
4.0 Legally Marketed Device
The SYNCHRON CX Delta Clinical Systems, claims substantial equivalence to the Beckman Coulter SYNCHRON CX Delta Clinical System currently in commercial distribution, FDA 510(k) Number K950958.
5.0 Device Description
The SYNCHRON CX Delta System determines creatinine concentration by means of the Jaffe rate method. A precise volume of sample is injected into the reaction cup with CRE3 reagent containing picric acid. Absorbance readings are taken at 520 nm between 19 to 25 seconds after sample introduction. The SYNCHRON CX Delta System utilizes a two level calibrator for the creatinine test. SYNCHRON CX
1
Calibrator is designed for optimal performance on the SYNCHRON CX Delta Clinical Systems. CX Calibrator is an aqueous based calibrator made by New England Reagent Laboratory (NERL) to Beckman Coulter specifications, This product is tested during manufacturing using standards traceable to National Institute of Standard and Technology (NIST) reference materials. The creatinine concentrations are established based on addition of weighed-in specific quantities of creatinine to achieve the appropriate level of each calibrator. Each calibrator level is packaged individually in 25 mL bottles, 6 to a package.
6.0 Intended Use
CRE3 reagent, when used in conjunction with SYNCHRON CX® Delta System(s) SYNCHRON® Systems CX Calibrator 1 and 2. is intended for the quantitative determination of Creatinine (CRE3) in human serum, plasma or urine.
Beckman Coulter SYNCHRON CX Calibrators 1, 2, and 3 are to be used for calibrating SYNCHRON CX Delta, CX® CE, and CX PRO Systems only.
7.0 Comparison to the Predicate (Description of the Modification to the Legally Marketed Device)
The modification to the creatinine module (CRE3) involves modification of the calibrator set points coded in the chemistry database. No formulation changes or system parameters have been modified with the exception of the calibrator set points. The modification to the CX Calibrator 1, 2 & 3 set points involves value assignment of the creatinine levels to values determined by a one time correlation of serum creatinine sample set to Isotope Dilution Mass Spectometery (IDMS). These new calibrator set points will replace the current values contained in the chemistry database. The product will continue to be manufactured in the same
2
manner as it is today. The creatinine level in each calibrator will still be based on addition of weighed-in specific values of creatinine.
.
Summary of Performance Data 8.0
Performance data from validation testing supports equivalency.
:
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Beckman Coulter, Inc. c/o Ms. Tara M. Viviani, Senior Regulatory Affairs Specialist 200 South Kraemer Blvd., M/S W-110 Brea, CA 92821
Re: K071280
Trade/Device Name: Synchron® CX Delta Clinical Systems Regulation Number: 21 CFR§ 862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Code: CGX, JIX Dated: May 04, 2007 Received: May 07, 2007
Dear Ms. Viviani:
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.
JUN - 1 2007
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 yours,
Jean M. Cooper, M.S., D.V.M.
Jean 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
5
Indications for Use
510(k) Number (if known): K071280
SYNCHRON® CX Delta Clinical Systems, Creatinine Test Device Name: Systems
Indications for Use:
Beckman Coulter SYNCHRON CX Calibrators 1, 2, and 3 are to be used for calibrating SYNCHRON CX Delta, CX® CE, and CX PRO Systems only.
CRE3 reagent, in conjunction with SYNCHRON CX® Delta Systems and SYNCHRON CX® Calibrators 1, 2 and 3 is intended for the quantitative determination of Creatinine (CRE3) in human serum, plasma or urine.
CLINICAL SIGNIFICANCE
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 Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 807 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)
Division Sign-Off
Office of In Vitro Dlagr
510(k) K071382
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