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.

Device Description

The SYNCHRON System Vancomycin (VANC) Reagent and Calibrator are designed for use on SYNCHRON CX (CX440CF/404PRO, CX5/6CE/5/5PRO, CX7/7RTS/7/47PRO, CX9ALX/9PRO) and LX (LX20/PRO) Systems. The assay is intended for use in the quantitative determination of vancomycin concentration in human serum or plasma. The reagent is supplied in two 100-test cartridges and is packaged separately from the six-level calibrator set.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the SYNCHRON® Systems Vancomycin Reagent and Calibrator, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined acceptance criteria in terms of performance thresholds. However, we can infer the performance metrics used for comparison.

Performance Metric	Acceptance Criteria (Implied by Predicate Performance / Regulatory Aims)	Reported Device Performance (SYNCHRON Vancomycin Assay)
Method Comparison
N	Sufficient sample size for statistical significance	100
Slope	Close to 1.0 (indicating proportional agreement)	1.096
Intercept	Close to 0.0 (indicating systematic agreement)	-2.63
r (Correlation Coefficient)	High (e.g., >0.95, indicating strong linear relationship)	0.983
Imprecision
Within-Run Imprecision	Low coefficient of variation (%C.V.) at different levels	Level 1: 5.3%
		Level 2: 1.7%
		Level 3: 1.9%
Total Imprecision	Low coefficient of variation (%C.V.) at different levels	Level 1: 7.0%
		Level 2: 2.2%
		Level 3: 2.5%
Reportable Range	Comparative to predicate, or clinically adequate	CX: 3.5 - 50 µg/mL LX: 3.5 - 40 µg/mL LX ORDAC: 30-60 µg/mL
Sensitivity	Comparative to predicate, or clinically adequate	3.5 µg/mL

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- Method Comparison: 100 patient serum specimens.
- Imprecision: 80 replicates (N) for each of the three levels tested (Level 1, Level 2, Level 3) for both within-run and total imprecision.
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It mentions "Serum patient specimens were analyzed," which typically implies prospective collection for such validation studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of in vitro diagnostic device (IVD) for quantitative measurement of an analyte like vancomycin does not typically rely on "experts" to establish ground truth in the same way an imaging or diagnostic AI model would.

Ground Truth Establishment for IVDs: The "ground truth" for method comparison and imprecision studies for an IVD is established by the predicate device (Abbott AxSYM Vancomycin Assay) and the reference analytical methods used to prepare the control samples for imprecision. The predicate device itself has undergone its own validation to establish performance against a known reference.

4. Adjudication Method (for the test set)

Not applicable. As noted above, this is an IVD for quantitative measurement, not a subjective diagnostic assessment requiring adjudication by multiple readers or experts. The comparison is between quantitative results.

5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in vitro diagnostic device for quantitative measurement of an analyte. It is not an imaging or AI-assisted diagnostic device used by human readers for interpretation, so an MRMC study is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, this is effectively a standalone performance evaluation. The SYNCHRON Vancomycin Assay is an automated system (algorithm/instrument + reagent) that generates a quantitative result directly. Its performance is assessed independently against a predicate device and through imprecision studies. Human input is limited to sample preparation and loading, and interpreting the final quantitative value; there's no "human-in-the-loop" decision-making assisted by the device in the sense of AI diagnostics.

7. The type of ground truth used

For Method Comparison: The results obtained from the Abbott AxSYM Vancomycin Assay on the same patient specimens served as the comparative "ground truth" or reference for the new SYNCHRON system.
For Imprecision: The "truth" is established by the known concentrations of the control samples (Level 1, Level 2, Level 3) used, which would have been meticulously prepared and verified using a highly accurate reference method.

8. The sample size for the training set

The document does not specify a separate "training set" sample size. For IVDs, assay development and internal validation (which might be analogous to "training") would typically involve a larger number of samples and controls during calibration and optimization processes. The presented data represents the performance validation study.

9. How the ground truth for the training set was established

As above, for IVDs, the "ground truth" during development/training would be established through:
- Reference Methods: Using highly accurate and precise reference methods (e.g., mass spectrometry, certified reference materials) to assign target values to calibrators and controls.
- Known Concentrations: Preparing samples with precisely known concentrations of the analyte.
- Comparison to Established Systems: Benchmarking against already established and validated commercial assays (like the predicate device mentioned).

Summary

{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	DocketNumber
SYNCHRON® SystemsVancomycin (VANC)Reagent and Calibrator	AxSYM® Vancomycin IIAssay	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® SystemsVANC Reagent andCalibrator	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: TurbidimetricInhibition ImmunoassayAxSYM: FluorescencePolarization Immunoassay(FPIA)
	Formulation	Specific to methodology
	Reportable Range	SYNCHRON:CX: 3.5 - 50 $\mu$ g/mLLX: 3.5 - 40 $\mu$ g/mLLX: ORDAC* 30-60 $\mu$ g/mLAxSYM: 2 - 100 $\mu$ g/mL
	Sensitivity	SYNCHRON: 3.5 $\mu$ g/mLAxSYM: 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
SYNCHRONVancomycin Assay	100	1.096	-2.63	0.983	Abbott AxSYMVancomycin 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}------------------------------------------------

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 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)

Over-the-Counter Use Optional Format 1-2-96

Regulation Number and Section

§ 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.