(89 days)
Not Found
No
The summary describes a turbidimetric immunoassay for quantitative determination of vancomycin concentration, which is a standard laboratory technique and does not mention any AI or ML components.
No
This device is a reagent and calibrator used for the quantitative determination of vancomycin concentration in human serum and plasma, which is a diagnostic function, not a therapeutic one.
Yes
The device is intended for the quantitative determination of vancomycin concentration, which provides information used to aid in diagnosis or patient management.
No
The device description clearly states it is a reagent and calibrator intended for use on specific SYNCHRON and LX Systems, which are hardware platforms. The submission describes physical components (reagent cartridges, calibrator set) and performance studies related to chemical analysis, not software functionality.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the quantitative determination of vancomycin concentration in human serum and plasma". This indicates that the device is used to test samples taken from the human body (in vitro) to provide diagnostic information.
- Device Description: The description confirms that the reagent and calibrator are used to determine vancomycin concentration in "human serum or plasma".
- Method of Analysis: The method used is a "turbidimetric immunoassay", which is a common technique for in vitro diagnostic testing.
- Performance Studies: The performance studies involve analyzing "Serum patient specimens", further supporting its use with human biological samples.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The SYNCHRON® Systems Vancomycin (VANC) Reagent, in conjunction with the SYNCHRON® Systems Vancomycin Calibrator set, is intended for the quantitative determination of vancomycin concentration in human serum and plasma on SYNCHRON Systems by turbidimetric immunoassay.
The SYNCHRON® Systems Vancomycin Calibrator, used in conjunction with THE OTHON® Vancomycin Reagent, is intended for use on the SYNCHRON Systems fof the calibration of Yancomycin.
Product codes
LEH
Device Description
The SYNCHRON System Vancomycin (VANC) Reagent and Calibrator are designed for use on SYNCHRON CX (CX440CF/404PRO, CX5/6CE/5/5PRO, C CX7/7RTS/7/47PRO, CX9ALX/9PRO) and LX (LX20/PRO) Systems.
The assay is intended for use in the qualitation of vancomycin concentration in human serum or plasma.
The reagent is packaged into 100-test cartidges and is packaged separately from the six-level calibrator set.
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 and imprecision experiments that relate results obtained from the SYNCHRON Vancomycin Assay to the Abbott AxSYM Vancomycin assay.
Method Comparison Study Results:
Analyte: SYNCHRON Vancomycin Assay
N: 100
Slope: 1.096
Intercept: -2.63
r: 0.983
Predicate Method: Abbott AxSYM Vancomycin Assay
*Serum patient specimens were analyzed in the range of 3.6 to 51.6 µg/mL vancomyucin. Data shown was collected using SYNCHRON LX Systems. Equivalency between SYNCHRON LX and SYNCHRON CX Systems has been established by correlation analysis.
Imprecision Study Results (SYNCHRON LX Vancomycin Assay):
Within-Run Imprecision:
Level 1: Mean (µg/mL) = 8.2, S.D. (%) = 0.44, %C.V. = 5.3, N = 80
Level 2: Mean (µg/mL) = 21.6, S.D. (%) = 0.37, %C.V. = 1.7, N = 80
Level 3: Mean (µg/mL) = 36.2, S.D. (%) = 0.69, %C.V. = 1.9, N = 80
Total Imprecision:
Level 1: Mean (µg/mL) = 8.2, S.D. (%) = 0.58, %C.V. = 7.0, N = 80
Level 2: Mean (µg/mL) = 21.6, S.D. (%) = 0.48, %C.V. = 2.2, N = 80
Level 3: Mean (µg/mL) = 36.2, S.D. (%) = 0.89, %C.V. = 2.5, N = 80
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Reportable Range:
SYNCHRON:
CX: 3.5 - 50 µg/mL
LX: 3.5 - 40 µg/mL
LX: ORDAC 30-60 µg/mL
AxSYM: 2 - 100 µg/mL
Sensitivity:
SYNCHRON: 3.5 µg/mL
AxSYM: 2 µg/mL
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
§ 862.3950 Vancomycin test system.
(a)
Identification. A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a stylized, circular graphic to the left of the company name. The name "BECKMAN COULTER" is written in bold, sans-serif font, with "BECKMAN" on the top line and "COULTER" on the bottom line.
510(k) Summary SYNCHRON® Systems Vancomycin Reagent and Calibrator
KD13076
1.0 Submitted By:
Mary Beth Tang Mary Begulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 961-3777 Fax: (714) 961-4123
Date Submitted: 2.0
September 12, 2001
Device Name(s): 3.0
- Proprietary Names: 3.1 Prophetary Names.
SYNCHRON® Systems Vancomycin Reagent and Calibrator - Classification Name: 3.2 Classmeations (21 CFR $ 862.3950) Vancomycin toxicology calibrator (21 CFR § 862.3200)
Predicate Device(s): 4.0
| Beckman Coulter | Predicate | Manufacturer | Docket
Number |
|------------------------------------------------------------------|-------------------------------|-------------------------------|------------------|
| SYNCHRON® Systems
Vancomycin (VANC)
Reagent and Calibrator | AxSYM® Vancomycin II
Assay | Abbott Laboratories,
Inc.* | K955851 |
*Abbott Laboratories, Inc., Abbott Park, IL
Description: 5.0
The SYNCHRON System Vancomycin (VANC) Reagent and Calibrator are designed for The SYNCHRON System valioning in (VANCHRON CX (CX440CF/404PRO, CX5/6CE/5/5PRO, C CX7/7RTS/7/47PRO, CX9ALX/9PRO) and LX (LX20/PRO) Systems.
CX7/7RTS/7/47PRO, CX9ALX/9PRO) and LX (LX20/PRO) Systems.
CX7/7RTS/7/47PRO, CX9ALX/9PRO) and LX (LX20/PRO) and expre The assay is CX7/7RTS/7/7PRO, CX9ALXJPPRO} and LX (EXEAN RO) of vancomycin concentration in human intended for use in the qualitians wo 100-test cartidges and is packaged separately from the six-level calibrator set.
Intended Use: 6.0
The SYNCHRON Systems Vancomycin (VANC) Reagent, in conjunction with the The SYNCHRON Systems Vancomyon Calibrator set, is intented for the quantititive SYNCHRON Systems Vancomycin concentration in human serum or plasma on SYNCHRON Systems.
The SYNCHRON Systems Vancomycin Calibrator, used in onlynntion with SYNCHRON Systems for the calibration of The SYNCHRON Systems Vancomych Calibrator, used in Only Children for the Californial of Vancomycin.
Beckman Coulter, Inc. 200 S. Kraemer Boulevard Brea, CA 92821
Mailing Address: 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000
Telephone: (714) 993-5321 Facsimile: (714) 961-4165 www.beckmancoulter.com Internet:
1
7.0 Comparison to Predicate(s):
| Assay | Aspect/Characteristic | Comments |
|---|---|---|
| SIMILARITIES | ||
| SYNCHRON® Systems | ||
| VANC Reagent and | ||
| Calibrator | Intended use | Same as predicate |
| Sample Type | ||
| Antibody source (mouse monoclonal) | ||
| Liquid-stable reagents and calibrators | ||
| Storage conditions (+2°C to +8°C) | ||
| DIFFERENCES | ||
| Methodology | SYNCHRON: Turbidimetric | |
| Inhibition Immunoassay | ||
| AxSYM: Fluorescence | ||
| Polarization Immunoassay | ||
| (FPIA) | ||
| Formulation | Specific to methodology | |
| Reportable Range | SYNCHRON: | |
| CX: 3.5 - 50 $\mu$ g/mL | ||
| LX: 3.5 - 40 $\mu$ g/mL | ||
| LX: ORDAC* 30-60 $\mu$ g/mL | ||
| AxSYM: 2 - 100 $\mu$ g/mL | ||
| Sensitivity | SYNCHRON: 3.5 $\mu$ g/mL | |
| AxSYM: 2 $\mu$ g/mL | ||
| Sample Size | SYNCHRON: | |
| 3 $\mu$ L, 2 $\mu$ L (LX ORDAC) | ||
| AxSYM: 150 $\mu$ L, 94 $\mu$ L (STAT) |
*ORDAC = Over Range Detection and Correction
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 companson and imprecision experiments that relate results obtained from the SYNCHRON Vancomycin Assay to the Abbott AxSYM Vancomycin assay.
| Method Comparison Study Results* | |
|---|---|
| ---------------------------------- | -- |
| Analyte | N | Slope | Intercept | r | Predicate Method |
|---|---|---|---|---|---|
| SYNCHRON | |||||
| Vancomycin Assay | 100 | 1.096 | -2.63 | 0.983 | Abbott AxSYM |
| Vancomycin Assay |
*Serum patient specimens were analyzed in the range of 3.6 to 51.6 µg/mL vancomyucin. Data shown was collected using SYNCHRON LX Systems. Equivalency between SYNCHRON LX and SYNCHRON CX Systems has been established by correlation analysis.
| Sample | Mean (µg/mL) | S.D. (%) | %C.V. | N |
|---|---|---|---|---|
| Within-Run Imprecision | ||||
| Level 1 | 8.2 | 0.44 | 5.3 | 80 |
| Level 2 | 21.6 | 0.37 | 1.7 | 80 |
| Level 3 | 36.2 | 0.69 | 1.9 | 80 |
| Total Imprecision | ||||
| Level 1 | 8.2 | 0.58 | 7.0 | 80 |
| Level 2 | 21.6 | 0.48 | 2.2 | 80 |
| Level 3 | 36.2 | 0.89 | 2.5 | 80 |
Estimated SYNCHRON LX Vancomvoin Assay Imprecision
The Summary of Safety and Effectiveness information for the SYNCHRON Systems Vancomycin Reagent and Calibrator are found in TAB 1 of this notice and are being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and implementing regulation 21 CFR 807.92.
Beckman Coulter, Inc., Section 510(k) Notification
SYNCHRON® Systems Vancomycin (VANC) Reagent and Calibrator 510(K) Summary
2
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, with three wavy lines representing the staff and a stylized bird-like form representing the serpent.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 2 2001
Ms. Mary Beth Tang Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 P.O. Box 8000 Brea, CA 92822-8000
Re: K013076
Trade/Device Name: SYNCHRON® Systems Vancomycin Reagent and Calibrator Regulation Number: 21 CFR 862.3950 Regulation Name: Vancomycin test system Regulatory Class: Class II Product Code: LEH Dated: November 28, 2001 Received: November 29, 2001
Dear Ms. Tangl:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket I his letter will and in you substantial equivalence of your device to a legally marketed nonification. "The Dir in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 Iditionally, for questions on the promotion and advertising of your device, (2017) 594-4565. Traditional (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small information on Jour responser Assistance at its toll-free number (800) 638-2041 or Manufactor Internation internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K013076
Device Name: SYNCHRON® Systems Vancomycin Reagent and Calibrator
Indications for Use:
The SYNCHRON® Systems Vancomycin (VANC) Reagent, in conjunction with the SYNCHRON® Systems Vancomycin Calibrator set, is intended for the quantitative determination of vancomycin concentration in human serum and plasma on SYNCHRON Systems by turbidimetric immunoassay.
The SYNCHRON® Systems Vancomycin Calibrator, used in conjunction with THE OTHON® Vancomycin Reagent, is intended for use on the SYNCHRON Systems fof the calibration of Yancomycin.
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | Division of Clinical Laboratory Devices |
| 510(k) Number | K613076 |
| (Division Sign-Off) | |
| 510(k) Number |
(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use Optional Format 1-2-96