(23 days)
Not Found
No
The document describes a chemical reagent and its use with laboratory instruments for quantitative determination of Creatinine. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is a reagent used for quantitative determination of creatinine concentration, which aids in diagnosis and treatment monitoring, but it does not directly provide therapy.
Yes
The intended use statement explicitly states that "Creatinine measurements are used in the diagnosis and treatment of renal diseases." This indicates that the device provides information used for diagnostic purposes.
No
The device description clearly states it is a reagent kit and is intended for use with specific hardware systems (UniCel® DxC 600/800 System(s), SYNCHRON® Systems). This indicates it is a physical component, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of Creatinine concentration in human serum or plasma." This is a measurement performed in vitro (outside the body) on a biological sample.
- Purpose: The 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." These are all diagnostic or monitoring purposes related to health conditions.
- Sample Type: It analyzes "human serum or plasma," which are biological specimens.
- Device Description: It describes a "reagent" and its use with specific laboratory instruments (UniCel® DxC 600/800 System(s), SYNCHRON® Systems). Reagents used for analyzing biological samples in a lab setting are characteristic of IVDs.
- Predicate Device: The mention of a predicate device (K042291; SYNCHRON Systems Creatinine Reagent) further confirms its classification as a medical device, and given its function, specifically an IVD.
All these factors 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 monitor therapeutic measures.
N/A
Intended Use / Indications for Use
CREA reagent, when used in conjunction with UniCel® DxC 600/800 System(s), SYNCHRON® Systems Multi Calibrator and the CRTX Application Sheet, is intended for the quantitative determination of Creatinine concentration in human serum or plasma as a User Defined Reagent (UDR) application.
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)
CGX
Device Description
The SYNCHRON Systems Creatinine (CREA) reagent is designed for optimal performance on SYNCHRON CX and UniCel DxC SYNCHRON instrument models. The reagent kit contains two 300-test cartridges that are packaged separately from the associated calibrator.
The candidate CRTX User Defined application is designed for optimal use on UniCel DxC Systems as a sample-blanked method to reduce bilirubin interference in serum and plasma samples.
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)
Performance data from verification testing supports equivalency.
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
L0600935
510(k) SUMMARY
1.0 Submitted By:
2002 8 2000
Annette Hellie Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-110 Brea, CA 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4123
2.0 Date Submitted
April 4, 2006
3.0 Device Name(s):
- 3.1 Proprietary Names SYNCHRON Systems Creatinine Reagent
- 3.2 Classification Names [862.1225 Creatinine test system]
4.0 Legally Marketed Device
SYNCHRON Systems Creatinine Reagent claims substantial The equivalence to the SYNCHRON Systems Creatinine Reagent currently in commercial distribution. FDA 510(k) Number K042291.
5.0 Device Description
The SYNCHRON Systems Creatinine (CREA) reagent is designed for optimal performance on SYNCHRON CX and UniCel DxC SYNCHRON instrument models. The reagent kit contains two 300-test cartridges that are packaged separately from the associated calibrator.
The candidate CRTX User Defined application is designed for optimal use on UniCel DxC Systems as a sample-blanked method to reduce bilirubin interference in serum and plasma samples.
1
6.0 Intended Use
CREA reagent, when used in conjunction with UniCel® DxC 600/800 System(s), SYNCHRON® Systems Multi Calibrator and the CRTX Application Sheet, is intended for the quantitative determination of Creatinine concentration in human serum or plasma as a User Defined Reagent (UDR) application.
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.
7.0 Comparison to the Predicate (Description of the Modification to the Legally Marketed Device)
The creatinine-triggered assay offers an alternative parameter set designed to work with the existing SYNCHRON Creatinine Reagent. The creatinine-triggered reagent application effectively reduces the interference seen with bilirubin when using the creatinine assay for serum and plasma samples. The creatinine-triagered assay uses a reaction trigger cycle employed for sample blanking. Use of the trigger cycle will reduce the sample throughput when compared to the system bar-coded creatinine assay.
8.0 Summary of Performance Data
Performance data from verification testing supports equivalency.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing health, services, and human aspects. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle emblem. The logo is presented in black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 8 2006
Ms. Annette Hellie Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. M/S W-110, PO Box 8000 Brea, CA 92822-8000
Re: K060935
Trade/Device Name: SYNCHRON® Systems Creatinine (CREA) Reagent Regulation Number: 21 CFR§ 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: CGX Dated: April 4, 2006 Received: April 5, 2006
Dear Ms. Hellie:
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 Ivqally 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) 276-0484. Also, please other 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 tolloffree miber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Gutierrez
Alberto Gutierrez, Ph.D. 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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page 1 of 1
510(k) Number (if known): K060935
SYNCHRON® Systems Creatinine (CREA) Reagent Device Name:
Indications for Use:
CREA reagent, when used in conjunction with UniCel® DxC 600/800 System(s), and SYNCHRON® Systems Multi Calibrator, is intended for the quantitative determination of Creatinine concentration 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.
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)
Carol C. Benson
ty
K060935
Beckman Coulter, Inc., Special 510(k) Device Modification SYNCHRON® Systems Creatinine Reagent File: CTRX s510k supplement.doc, 3/06