(59 days)
SYNCHRON@ Systems, UniCel@ DxC Systems, SYNCHRON@ Systems AQUA CAL 1 and 2, SYNCHRON CX@ Calibrator Level 1 and 2
No
The summary describes a chemical reagent and its performance in standard laboratory tests, with no mention of AI or ML.
No
The device is a reagent for the quantitative determination of creatinine concentration, used for diagnosis and monitoring of renal diseases, but it does not directly treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" states that "Creatinine measurements are used in the diagnosis and treatment of renal diseases". This indicates the device aids in diagnosis.
No
The device description clearly states it is a "reagent kit" containing "two 200-test cartridges," which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the reagent is for the "quantitative determination of creatinine (CR-E) concentration in human serum, plasma or urine." This is a measurement performed in vitro (outside the body) on biological samples.
- Purpose: The 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." This directly relates to providing information for medical diagnosis and treatment, which is a key characteristic of an IVD.
- Device Description: The description details a "reagent" used to measure a substance in biological samples using an "enzymatic method" with a "photometric end-point reaction." This is a typical description of an IVD reagent used in a laboratory setting.
- Performance Studies: The document includes performance studies like method comparison and precision, which are standard evaluations for IVD devices to demonstrate their accuracy and reliability for clinical use.
- Predicate Device: The mention of a "Predicate Device" with a K number (K071283) indicates that this device is being compared to a previously cleared IVD, further confirming its classification as an IVD.
All these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications 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.
Product codes
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
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
Prescription Use
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)
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, linearity, and imprecision experiments.
Serum Method Comparison Summary:
Candidate: Enzymatic Creatinine (CR-E) Reagent
Platform: CX7 PRO, DxC800
Slope: 0.997 (CX7 PRO), 0.991 (DxC800)
Intercept: -0.002 (CX7 PRO), 0.012 (DxC800)
R: 1.000 (CX7 PRO, DxC800)
N: 78 (CX7 PRO), 80 (DxC800)
Predicate Method: SYNCHRON Systems Creatinine (CR-S) Reagent
Urine Method Comparison Summary:
Candidate: Enzymatic Creatinine (CR-E) Reagent
Platform: DxC800
Slope: 0.988
Intercept: -3.096
R: 0.998
N: 66
Predicate Method: SYNCHRON Systems Creatinine (CR-S) Reagent
SYNCHRON Systems Enzymatic Creatinine (CR-E) Reagent Precision Study Results (on SYNCHRON CX7 PRO Clinical System):
Within-Run Imprecision:
Level 1: Mean 0.62 mg/dL, S.D. 0.01, %C.V. 1.4, N 80
Level 2: Mean 4.16 mg/dL, S.D. 0.02, %C.V. 0.5, N 80
Level 3: Mean 7.69 mg/dL, S.D. 0.02, %C.V. 0.3, N 80
Human Pool: Mean 1.50 mg/dL, S.D. 0.02, %C.V. 1.0, N 80
Total Imprecision:
Level 1: Mean 0.62 mg/dL, S.D. 0.01, %C.V. 1.5, N 80
Level 2: Mean 4.16 mg/dL, S.D. 0.02, %C.V. 0.6, N 80
Level 3: Mean 7.69 mg/dL, S.D. 0.04, %C.V. 0.5, N 80
Human Pool: Mean 1.50 mg/dL, S.D. 0.02, %C.V. 1.0, N 80
Precision Study Results on UniCel DxC 800 SYNCHRON Clinical System:
Within-Run Imprecision:
Serum Level 1: Mean 0.64 mg/dL, S.D. 0.01, %C.V. 2.1, N 80
Serum Level 2: Mean 4.09 mg/dL, S.D. 0.01, %C.V. 0.3, N 80
Serum Level 3: Mean 7.56 mg/dL, S.D. 0.03, %C.V. 0.3, N 80
Serum Human Pool: Mean 1.50 mg/dL, S.D. 0.01, %C.V. 0.7, N 80
Urine Level 1: Mean 66.45 mg/dL, S.D. 0.31, %C.V. 0.5, N 80
Urine Level 2: Mean 146.61 mg/dL, S.D. 0.60, %C.V. 0.4, N 80
Total Imprecision:
Serum Level 1: Mean 0.64 mg/dL, S.D. 0.02, %C.V. 2.5, N 80
Serum Level 2: Mean 4.09 mg/dL, S.D. 0.03, %C.V. 0.7, N 80
Serum Level 3: Mean 7.56 mg/dL, S.D. 0.06, %C.V. 0.8, N 80
Serum Human Pool: Mean 1.50 mg/dL, S.D. 0.01, %C.V. 0.9, N 80
Urine Level 1: Mean 66.45 mg/dL, S.D. 0.68, %C.V. 1.0, N 80
Urine Level 2: Mean 146.61 mg/dL, S.D. 1.47, %C.V. 1.0, N 80
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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Summary of Safety & Effectiveness SYNCHRON® Systems Enzymatic Creatinine (CR-E) Reagent
1.0 Submitted By:
Marine Bovaiian 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
Date Submitted: 2.0
June 11, 2009
3.0 Device Name(s):
- 3.1 Proprietary Names SYNCHRON® Systems Enzymatic Creatinine (CR-E) Reagent
- 3.2 Classification Name Enzymatic Method Creatinine (21 CFR § 862.1225)
4.0 Predicate Device:
| Candidate(s) | Predicate | Manufacturer | Docket
Number |
|------------------------------------------------------------|-----------------------------------------------|-------------------------|------------------|
| SYNCHRON Systems
Enzymatic Creatinine (CR-E)
Reagent | SYNCHRON Systems
Creatinine (CR-S) Reagent | Beckman
Coulter, Inc | K071283 |
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® 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).
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.
AUG 1 4 2009
1
Comparison to Predicate(s): 7.0
The following table shows similarities and differences between the candidate Enzymatic Creatinine (CR-E) Reagent and the predicate identified in Section 4.0 of this summary.
| Similarities | ||
|---|---|---|
| SYNCHRON | ||
| Systems | ||
| Enzymatic | ||
| Creatinine | ||
| (CR-E) | ||
| Reagent | Intended Use | Same |
| Sample Types | Same for the LX/DxC Systems | |
| Instrument Platforms | Same | |
| Calibrator | Same | |
| Analytical range (Urine) | Same | |
| Differences | ||
| SYNCHRON | ||
| Systems | ||
| Enzymatic | ||
| Creatinine | ||
| (CR-E) | ||
| Reagent | Analytical range | |
| (Serum and Plasma) | CR-E Reagent: 0.2 - 25.0 mg/dL | |
| CR-S Reagent: 0.3 - 25.0 mg/dL | ||
| Sample Types | CR-E Reagent: Plasma and Serum for CX Systems | |
| CR-S Reagent: Plasma, Serum and Urine for CX | ||
| Systems | ||
| Sample volume | CR-E Reagent: 10 µl (Serum, Plasma and Urine) | |
| Urine sample is diluted by the | ||
| system at ratio of 1:10. | ||
| CR-S Reagent: 20 µl Serum and Plasma, 3 µl Urine | ||
| Reaction Type | ||
| (Methodology) | CR-E Reagent: Enzymatic method | |
| CR-S Reagent: Modified rate Jaffe method | ||
| Calibration Frequency | CR-E Reagent: Every 14 days | |
| CR-S Reagent: Every 5 days on LX/DxC Systems | ||
| Every 7 days on CX Systems | ||
| Detection Wavelength | CR-E Reagent: 560 nm (Primary Wavelength) | |
| CR-S Reagent: 520 nm (Primary Wavelength) |
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8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, linearity, and imprecision experiments.
Serum Method Comparison Summary
| Candidate | Platform | Slope | Intercept | R | N | Predicate Method |
|---|---|---|---|---|---|---|
| Enzymatic | ||||||
| Creatinine | ||||||
| (CR-E) Reagent | CX7 PRO | 0.997 | -0.002 | 1.000 | 78 | SYNCHRON |
| Systems Creatinine | ||||||
| (CR-S) Reagent | ||||||
| DxC800 | 0.991 | 0.012 | 1.000 | 80 |
Urine Method Comparison Summary
| Candidate | Platform | Slope | Intercept | R | N | Predicate Method |
|---|---|---|---|---|---|---|
| Enzymatic | ||||||
| Creatinine | ||||||
| (CR-E) Reagent | DxC800 | 0.988 | -3.096 | 0.998 | 66 | SYNCHRON |
| Systems Creatinine | ||||||
| (CR-S) Reagent |
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SYNCHRON Systems Enzymatic Creatinine (CR-E) Reagent Precision Study Results
| Sample | Mean
(mg/dL) | S.D. | %C.V. | N |
|------------------------|-----------------|------|-------|----|
| Within-Run Imprecision | | | | |
| Level 1 | 0.62 | 0.01 | 1.4 | 80 |
| Level 2 | 4.16 | 0.02 | 0.5 | 80 |
| Level 3 | 7.69 | 0.02 | 0.3 | 80 |
| Human Pool | 1.50 | 0.02 | 1.0 | 80 |
| Total Imprecision | | | | |
| Level 1 | 0.62 | 0.01 | 1.5 | 80 |
| Level 2 | 4.16 | 0.02 | 0.6 | 80 |
| Level 3 | 7.69 | 0.04 | 0.5 | 80 |
| Human Pool | 1.50 | 0.02 | 1.0 | 80 |
Precision Study Results on SYNCHRON CX7 PRO Clinical System
Precision Study Results on UniCel DxC 800 SYNCHRON Clinical System
F
| | Sample | Mean
(mg/dL) | S.D. | %C.V. | N |
|------------------------|------------|-----------------|------|-------|----|
| Within-Run Imprecision | | | | | |
| Serum | Level 1 | 0.64 | 0.01 | 2.1 | 80 |
| | Level 2 | 4.09 | 0.01 | 0.3 | 80 |
| | Level 3 | 7.56 | 0.03 | 0.3 | 80 |
| | Human Pool | 1.50 | 0.01 | 0.7 | 80 |
| Urine | Level 1 | 66.45 | 0.31 | 0.5 | 80 |
| | Level 2 | 146.61 | 0.60 | 0.4 | 80 |
| Total Imprecision | | | | | |
| Serum | Level 1 | 0.64 | 0.02 | 2.5 | 80 |
| | Level 2 | 4.09 | 0.03 | 0.7 | 80 |
| | Level 3 | 7.56 | 0.06 | 0.8 | 80 |
| | Human Pool | 1.50 | 0.01 | 0.9 | 80 |
| Urine | Level 1 | 66.45 | 0.68 | 1.0 | 80 |
| | Level 2 | 146.61 | 1.47 | 1.0 | 80 |
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.
. `
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Beckman Coulter, Inc. c/o Ms. Marine Boyajian Senior Regulatory Affairs Specialist 200 S Kraemer Blvd., M/S W-110 Brea, CA 92822
AUG 1 4 2009
Re: K091742
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: June 11, 2009 Received: June 16, 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.goy/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,
G.C.H.
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indication for Use
510(k) Number (if known):
091742
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) soncentration 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)
Over the
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benam
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091742
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