(83 days)
Not Found
No
The description details a standard enzymatic assay for measuring carbon dioxide, relying on chemical reactions and spectrophotometric measurement. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is a reagent for the quantitative determination of Carbon Dioxide in human serum or plasma, which is a diagnostic purpose, not a therapeutic one.
Yes
The device is intended for the quantitative determination of Carbon Dioxide in human serum or plasma, which is a measurement used to aid in clinical diagnosis.
No
The device is a reagent kit used with specific hardware systems (UniCel® DxC 600/800 System(s) and SYNCHRON® Systems AQUA CAL 1 and 3) for quantitative determination of Carbon Dioxide. It is a chemical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "intended for the quantitative determination of Carbon Dioxide in human serum or plasma." This is a diagnostic test performed on biological samples in vitro (outside the body).
- Device Description: The description details a reagent used in a laboratory setting to measure a specific analyte (Carbon Dioxide) in human samples using an enzymatic method and spectrophotometric measurement. This is characteristic of an IVD.
- Performance Studies: The document includes performance studies like method comparison and precision, which are standard for demonstrating the analytical performance of an IVD.
- Predicate Device: The mention of a predicate device (K042291; UniCel DxC 600/800 SYNCHRON Clinical Systems CO2 rate pH) further confirms its classification as a medical device, specifically an IVD, as predicate devices are used to demonstrate substantial equivalence for regulatory purposes.
N/A
Intended Use / Indications for Use
CO2E reagent, when used in conjunction with UniCel® DxC 600/800 System(s) and SYNCHRON® Systems AQUA CAL 1 and 3, is intended for the quantitative determination of Carbon Dioxide in human serum or plasma.
Product codes (comma separated list FDA assigned to the subject device)
KHS
Device Description
The SYNCHRON Enzymatic CO2 (CO2E) Reagent is intended for use in the quantitative determination of Carbon Dioxide concentration in human serum or plasma. The SYNCHRON Systems CO2E assay is an enzymatic method utilizing phosphoenolpyruvate carboxylase (PEPC) and a stabilized NADH analog in two coupled enzymatic reactions. In the first reaction. PEPC catalyzes the reaction between phosphoenolpyruvate and HCO3 to yield oxaloacetate and inorganic phosphate. In the second step, oxaloacetate is reduced by a stable NADH analog to malate in the presence of malate dehydrogenase (MDH). The resulting decrease in absorbance at 410 nm is spectrophotometrically measured and directly proportional to the CO2 concentration in the test sample via measurement of bicarbonate ions (HCO3). The SYNCHRON DxC Systems utilize a two-level calibrator for the Carbon Dioxide assay.
The SYNCHRON Enzymatic CO2 (CO2E) Reagent is designed for optimal performance on the UniCel DxC SYNCHRON Clinical Systems (UniCel DxC 600/800 SYNCHRON and UniCel DxC 600i/660i/860i/860i/880i SYNCHRON Access Clinical Systems). The reagent kit contains two 300-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
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)
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.
| Candidate | Platform | Slope | Intercept | R | N | Predicate Method |
|---|---|---|---|---|---|---|
| SYNCHRON Systems Enzymatic CO2 (CO2E) Reagent | UniCel DxC | 0.974 | 0.514 | 0.996 | 143 | UniCel DxC 800 SYNCHRON Clinical System CO2 rate pH |
SYNCHRON Systems Enzymatic CO2 (CO2E) Reagent Precision Study Results
| Sample | Mean (mmol/L) | S.D. (mmol/L) | %C.V. | N |
|---|---|---|---|---|
| Within-Run Imprecision | ||||
| Level 1 | 11.50 | 0.39 | 3.4 | 80 |
| Level 2 | 27.50 | 0.52 | 1.9 | 80 |
| Total Imprecision | ||||
| Level 1 | 11.50 | 0.53 | 4.6 | 80 |
| Level 2 | 27.50 | 0.68 | 2.5 | 80 |
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
§ 862.1160 Bicarbonate/carbon dioxide test system.
(a)
Identification. A bicarbonate/carbon dioxide test system is a device intended to measure bicarbonate/carbon dioxide in plasma, serum, and whole blood. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.(b)
Classification. Class II.
0
K09115-3
Summary of Safety & Effectiveness SYNCHRON® Systems Enzymatic CO2 (CO2E) Reagent
1.0 Submitted Bv:
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
JUL 1 3 2009
Date Submitted: 2.0
April 16, 2009
3.0 Device Name(s):
- 3.1 Proprietary Names SYNCHRON® Systems Enzymatic CO2 (CO2E) Reagent
- 3.2 Classification Name Bicarbonate/carbon dioxide test system (21 CFR § 862.1160)
4.0 Predicate Device:
| Candidate(s) | Predicate | Manufacturer | Docket
Number |
|--------------------------------------------------|----------------------------------------------------------------|-------------------------|------------------|
| SYNCHRON Systems
Enzymatic CO2 (CO2E) Reagent | UniCel DxC 600/800
SYNCHRON Clinical
Systems CO2 rate pH | Beckman
Coulter, Inc | K042291 |
5.0 Description:
The SYNCHRON Enzymatic CO2 (CO2E) Reagent is intended for use in the quantitative determination of Carbon Dioxide concentration in human serum or plasma. The SYNCHRON Systems CO2E assay is an enzymatic method utilizing phosphoenolpyruvate carboxylase (PEPC) and a stabilized NADH analog in two coupled enzymatic reactions. In the first reaction. PEPC catalyzes the reaction between phosphoenolpyruvate and HCO3 to yield oxaloacetate and inorganic phosphate. In the second step, oxaloacetate is reduced by a stable NADH analog to malate in the presence of malate dehydrogenase (MDH). The resulting decrease in absorbance at 410 nm is spectrophotometrically measured and directly proportional to the CO2 concentration in the test sample via measurement of bicarbonate ions (HCO3). The SYNCHRON DxC Systems utilize a twolevel calibrator for the Carbon Dioxide assay.
The SYNCHRON Enzymatic CO2 (CO2E) Reagent is designed for optimal performance on the UniCel DxC SYNCHRON Clinical Systems (UniCel DxC 600/800 SYNCHRON and UniCel DxC 600i/660i/860i/860i/880i SYNCHRON Access Clinical Systems). The reagent kit contains two 300-test cartridges that are packaged separately from the associated calibrator.
6.0 Intended Use:
CO2E reagent, when used in conjunction with UniCel® DxC 600/800 System(s) and SYNCHRON® Systems AQUA CAL 1 and 3, is intended for the quantitative determination of Carbon Dioxide in human serum or plasma.
Beckman Coulter. Inc., Section 510(k) Notification SYNCHRON® Systems Enzymatic CO2 (CO2E) Reagent SYN CO2E 510K Summary.doc
1
Clinical Significance:
Carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
7.0 Comparison to Predicate(s):
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
| Similarities | ||
|---|---|---|
| SYNCHRON | ||
| Systems | ||
| Enzymatic | ||
| CO2 (CO2E) | ||
| Reagent | Intended Use | Same |
| Sample Types | Same | |
| Analytical Sensitivity | Same | |
| Calibrator | Same | |
| Differences | ||
| SYNCHRON | ||
| Systems | ||
| Enzymatic | ||
| CO2 (CO2E) | ||
| Reagent | Analytical range | CO2E Reagent: 5.0 - 45.0 mmol/L |
| CO2 ISE Reagent: 5.0 - 50.0 mmol/L | ||
| Sample volume | CO2E Reagent: 6 μl | |
| CO2 ISE Reagent: 40 μl | ||
| Reaction Type | ||
| (Methodology) | CO2E Reagent: enzymatic method | |
| CO2 ISE Reagent: pH rate change method | ||
| Instrument Platforms | CO2E Reagent: UniCel DxC 600/800 Systems | |
| CO2 ISE Reagent: SYNCHRON LX and UniCel DxC 600/800 Systems | ||
| Calibration Frequency | CO2E Reagent: every 72 hours | |
| CO2 ISE Reagent: every 24 hours |
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.
| Candidate | Platform | Slope | Intercept | R | N | Predicate Method |
|---|---|---|---|---|---|---|
| SYNCHRON | ||||||
| Systems | ||||||
| Enzymatic CO2 | ||||||
| (CO2E) Reagent | UniCel | |||||
| DxC | 0.974 | 0.514 | 0.996 | 143 | UniCel DxC 800 | |
| SYNCHRON Clinical | ||||||
| System CO2 rate pH |
SYNCHRON Systems Enzymatic CO2 (CO2E) Reagent Precision Study Results
| Sample | Mean
(mmol/L) | S.D.
(mmol/L) | %C.V. | N |
|------------------------|------------------|------------------|-------|----|
| Within-Run Imprecision | | | | |
| Level 1 | 11.50 | 0.39 | 3.4 | 80 |
| Level 2 | 27.50 | 0.52 | 1.9 | 80 |
| Total Imprecision | | | | |
| Level 1 | 11.50 | 0.53 | 4.6 | 80 |
| Level 2 | 27.50 | 0.68 | 2.5 | 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.
Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON® Systems Enzymatic CO2 (CO2E) Reagent SYN CO2E 510K_Summary.doc
Page 2 of 2
April 16, 2009
2
| See OMB Statement on Reverse. Form Approved: OMB No. 0910-0616, Expiration Date: 06-30-2008 |
|---|
| --------------------------------------------------------------------------------------------- |
See OMB Statement on Reverse. Form Approved: OMB No. 0910-0616, Expiration Date: 06-30-2008
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Certification of Compliance, under 42 U.S.C. § 282(j)(5)(B), with
Requirements of ClinicalTrials.gov Data Bank (42 U.S.C. § 282(j))
(For submission with an application/submission, including amendments, supplements, and resubmissions, under §§ 505, 515, 520(m), or 510(k) of the
Federal Food, Drug, and Cosmetic Act or § 351 of the Public Health Service Act.)
| 1. NAME OF SPONSOR/APPLICANT/SUBMITTER | Marine Boyajian / Beckman Coulter, Inc. / Chemistry Systems Business Center |
|---|---|
| 2. DATE OF THE APPLICATION/SUBMISSION | |
| WHICH THIS CERTIFICATION ACCOMPANIES | 04/17/2009 |
| 3. ADDRESS (Number, Street, State, and ZIP Code) | 200 S. Kraemer Blvd. |
| M/S W-110 | |
| Brea, CA 92821 | |
| US | |
| 4. TELEPHONE AND FAX NUMBER | |
| (Include Area Code) | (Tel.) (714) 961 - 6536 |
| (Fax) (714) 961 - 4234 |
PRODUCT INFORMATION
| 5. FOR DRUGS/BIOLOGICS: Include Any/All Available Established, Proprietary and/or Chemical/Biochemical/Blood/Cellular/Gene Therapy Product Name(s)
FOR DEVICES: Include Any/All Common or Usual Name(s), Classification, Trade or Proprietary or Model Name(s) and/or Model Number(s)
| (Attach extra pages as necessary) | SYNCHRON Systems Enzymatic CO2 (CO2E) Reagent |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------- |
APPLICATION / SUBMISSION INFORMATION
| 6. TYPE OF APPLICATION/SUBMISSION WHICH THIS CERTIFICATION ACCOMPANIES | |
|---|---|
| IND NDA ANDA BLA PMA HDE 510(k) PDP Other | |
| 7. INCLUDE IND/NDA/ANDA/BLA/PMA/HDE/510(k)/PDP/OTHER NUMBER (If number previously assigned) | |
| 8. SERIAL NUMBER ASSIGNED TO APPLICATION/SUBMISSION WHICH THIS CERTIFICATION ACCOMPANIES |
CERTIFICATION STATEMENT / INFORMATION
| 9. CHECK ONLY ONE OF THE FOLLOWING BOXES (See instructions for additional information and explanation) | |
|---|---|
| A. I certify that the requirements of 42 U.S.C. § 282(j), Section 402(j) of the Public Health Service Act, enacted by 121 Stat. 823, Public Law | |
| 110-85, do not apply because the application/submission which this certification accompanies does not reference any clinical trial. | |
| B. I certify that the requirements of 42 U.S.C. § 282(j), Section 402(j) of the Public Health Service Act, enacted by 121 Stat. 823, Public Law | |
| 110-85, do not apply to any clinical trial referenced in the application/submission which this certification accompanies. | |
| C. I certify that the requirements of 42 U.S.C. § 282(j), Section 402(j) of the Public Health Service Act, enacted by 121 Stat. 823, Public Law | |
| 110-85, apply to one or more of the clinical trials referenced in the application/submission which this certification accompanies and that | |
| those requirements have been met. |
| 10. IF YOU CHECKED BOX C, IN NUMBER 9, PROVIDE THE NATIONAL CLINICAL TRIAL (NCT) NUMBER(S) FOR ANY "APPLICABLE CLINICAL TRIAL(S)."
UNDER 42 U.S.C. § 282(j)(1)(A)(i), SECTION 402(j)(1)(A)(i) OF THE PUBLIC HEALTH SERVICE ACT, REFERENCED IN THE APPLICATION/
| SUBMISSION WHICH THIS CERTIFICATION ACCOMPANIES (Attach extra pages as necessary) | |
|---|---|
| NCT Number(s): |
The undersigned declares, to the best of her/his knowledge, that this is an accurate, true, and complete submission of information. I understand that the
failure to submit the certification required by 42 U.S.C. § 282(j)(5)(B), section 402(j)(5)(B) of the Public Health Service Act and the knowing submission
of a false certification under such section are prohibited acts under 21 U.S.C. § 331, section 301 of the Federal Food, Drug, and Cosmetic Act.
Warning: A willfully and knowingly false statement is a criminal offense, U.S. Code, title 18, section 1001.
| 11. SIGNATURE OF SPONSOR/APPLICANT/SUBMITTER OR AN
| AUTHORIZED REPRESENTATIVE (Sign) | 12. NAME AND TITLE OF THE PERON WHO SIGNED IN NO. 11 | |
|---|---|---|
| (Name) Marine Boyajian | ||
| (Title) Senior Regulatory Affairs Specialist | ||
| 13. ADDRESS (Number, Street, State, and ZIP Code) (of person identified | ||
| in No. 11 and 12) | 14. TELEPHONE AND FAX NUMBER | |
| (Include Area Code) | 15. DATE OF | |
| CERTIFICATION | ||
| 200 S. Kraemer Blvd. | ||
| M/S W-110 | ||
| Brea, CA 92821 | ||
| US | (Tel.) (714) 961 - 6536 | |
| (Fax) (714) 961 - 4234 | 04/17/2009 |
FDA-3674 (1/08) (FRONT)
PSC Graphics: (301) 443-1090 EF ... . ... ...
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 South Kraemer Blvd., M/S W-110 Brea, CA 92822-8000
JUL 1 8 2009
Re: K091153
Trade name: Synchron® Systems Enzymatic CO2 (CO2E) Reagent Regulation Number: 21 CFR 862.1160 Regulation Name: Bicarbonate/carbon dioxide Test System Regulatory Class: Class II Product Code: KHS Dated: April 20, 2009 Received: April 22, 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).
4
Page 2
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 vours.
g.c.
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
5
Indication for Use
510(k) Number (if known): んつ91153
Device Name: SYNCHRON® Systems Enzymatic CO2 (CO2E) Reagent
Indication For Use:
CO2E reagent, when used in conjunction with UniCel® DxC 800 System and SYNCHRON® Systems AQUA CAL 1 and 3, is intended for the quantitative determination of Carbon Dioxide in human serum or plasma.
Clinical Significance
Carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance
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 (OVD)
Carol C. Benson
Revision Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091153
Page 1 of 1