MA reagent, when used in conjunction with SYNCHRON CX® System(s) and SYNCHRON CX® MA Calibrator, is intended for the quantitative determination of albumin (MA) concentration in human urine. Measurement of albumin in urine aids in the diagnosis of kidney dysfunction.

Device Description

Synchron Systems Microalbumin (MA) reagent is intended for the quantitative determination of albumin in urine. MA reagent is used to measure the albumin concentration by a turbidimetric method. In the reaction, albumin combines with specific antibody to form insoluble antigen-antibody complexes. The Synchron System(s) automatically proportions the appropriate sample and reagent volumes into the cuvette. The ratio used is one part sample to 24 parts reagent. The system monitors the change in absorbance at 380 nanometers. This change in absorbance is proportional to the concentration of albumin in the sample and is used by the system to calculate and express albumin concentration based upon a non-linear calibration curve.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the SYNCHRON® Systems Microalbumin (MA) Reagent, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes performance characteristics rather than explicit acceptance criteria with pre-defined thresholds. However, we can infer the desired performance from the reported results and the comparison to the predicate device. The study aims to demonstrate substantial equivalence to the predicate.

Performance Metric	Acceptance Criteria (Inferred)	Reported Device Performance (SYNCHRON® Systems MA Reagent)
Method Comparison (Correlation with Predicate)	High correlation (R close to 1), slope close to 1, intercept close to 0 with the predicate.	Slope: 0.990Intercept: -0.11R: 0.987
Within-Run Precision (CV)	Low coefficient of variation (CV) at different concentration levels.	Level 1 (0.8 mg/dL): 9.7%Level 2 (3.0 mg/dL): 4.5%Level 3 (40.1 mg/dL): 1.0%
Total Precision (CV)	Low coefficient of variation (CV) across multiple runs and days.	Level 1 (0.8 mg/dL): 16.3%Level 2 (3.0 mg/dL): 7.5%Level 3 (40.1 mg/dL): 1.5%
Measuring Range (Initial)	Wider or comparable to predicate.	0.2 - 30 mg/dL (Predicate: 0.2 - 4.0 mg/dL)
Measuring Range (Extended)	Wider or comparable to predicate, with effective extension methods.	24 - 97 mg/dL (achieved via smaller sample size) (Predicate: 4.0 - 864.0 mg/dL via on-line dilutions)

Study Information

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

Method Comparison (N): 111 (samples)
Precision Studies (N): 80 (measurements per level for both within-run and total imprecision)
Data Provenance: Not explicitly stated (e.g., country of origin). The document implies these are laboratory-generated data for performance validation. It is retrospective in the sense that the data used to prove substantial equivalence was collected prior to the 510(k) submission.

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

Not applicable. This device is a quantitative diagnostic test for a chemical analyte (albumin). The "ground truth" for the test set is established by the reference method (predicate device measurements) and the intrinsic chemical properties/concentrations of the samples used in the precision studies, not by expert interpretation.

4. Adjudication Method for the Test Set:

Not applicable. See point 3.

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 a reagent for an automated laboratory instrument, not an AI-assisted diagnostic tool that involves human readers/interpreters in the diagnostic process.

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

Yes, a standalone performance study was done. The entire performance evaluation (method comparison, precision data) for the SYNCHRON® Systems Microalbumin (MA) Reagent is a standalone evaluation of the device's analytical performance on the SYNCHRON CX® System, without human interpretation as part of the primary measurement.

7. The Type of Ground Truth Used:

Reference Method/Quantitative Measurement: For the method comparison, the "ground truth" is the quantitative measurement provided by the legally marketed predicate device (IMMAGE Microalbumin (MA) Reagent). For precision, the "ground truth" for each sample level is its mean concentration as determined by repeated measurements.

8. The Sample Size for the Training Set:

Not explicitly stated in terms of a separate "training set" for an algorithm. For this type of device (chemical reagent for an automated system), "training" generally refers to the development and optimization of the reagent formulation and the instrument's calibration curve. The document mentions a "6 level non-linear calibration curve" for the Synchron CX systems, which suggests calibration data were used to establish the assay's operational parameters, but the specific sample size for this is not provided.

9. How the Ground Truth for the Training Set was Established:

Not explicitly detailed as a distinct "ground truth" for a training set. The calibration curve construction (mentioned as "6 level non-linear calibration curve") would involve using calibrator materials with known, accurately determined concentrations of albumin. These concentrations would be established through a traceable reference method or gravimetric preparation.

Summary

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K082251

APR - 8 2009

Summary of Safety & Effectiveness SYNCHRON® Systems Microalbumin (MA) Reagent

1.0 Submitted By:

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

Date Submitted: 2.0

August 7, 2008

Device Name(s): 3.0

3.1 Proprietary Names SYNCHRON® Systems Microalbumin (MA) Reagent

3.2 Classification Name Albumin immunological test system (21 CFR § 866.5040)

Predicate Device: 4.0

Candidate(s)	Predicate	Manufacturer	DocketNumber
Synchron SystemsMicroalbumin (MA) Reagent	IMMAGE ImmunochemistrySystems Microalbumin (MA)Reagent	BeckmanCoulter, Inc	K965035

5.0 Description:

6.0 Intended Use:

Beckman Coulter, Inc., Section 510(k) Notification Page 1 of 2 SYNCHRON® Systems Microalbumin (MA) SYNCHRON® Systems Microalbumin (MA) Reagent, Revised SYN MA 510K_Summary 04.07.09 no LX.doc August, 2008

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7.0 Comparison to Predicate(s):

	Similarities
SynchronMicroalbumin(MA) Reagent	Intended Use	Same
	Antibody	Goat anti-human albumin polyclonal Ab.Same as Immage MA Reagent
	Buffer	Phosphate buffer with PEG
	Single pointadjustedCalibration	MA on LX and DxC platforms and IMMAGE MAuse single point adjusted non-linear calibration.
	Differences
SynchronMicroalbumin(MA) Reagent	Initial measuringrange	Immage: 0.2 - 4.0 mg/dLSynchron Systems: 0.2 - 30 mg/dL
	Extendedmeasuring range	Immage: 4.0 - 864.0 mg/dL(achieved via on-line dilutions)Synchron Systems: 24 - 97 mg/dL(achieved via smaller sample size)
	Calibration	MA on Sychron CX systems uses 6 level non-linear calibration curve.

The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.

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.

Method Comparison Study Results

Candidate	Slope	Intercept	R	N	Predicate Method
CX SystemsSynchron Microalbumin(MA) Reagent(0.4 to 26.1 mg/L)	0.990	-0.11	0.987	111	IMMAGEMicroalbumin (MA)Reagent

SYNCHRON CX Systems Precision Study Results

Sample	Mean(mg/dL)	S.D.(mg/dL)	%C.V.	N
Within-Run Imprecision
Level 1	0.8	0.08	9.7	80
Level 2	3.0	0.14	4.5	80
Level 3	40.1	0.42	1.0	80
Total Imprecision
Level 1	0.8	0.13	16.3	80
Level 2	3.0	0.23	7.5	80
Level 3	40.1	0.59	1.5	80

Beckman Coulter, Inc., Section 510(k) Notification Page 2 of 2 SYNCHRON® Systems Microalbumin (MA) SYNCHRON® Systems Microalbumin (MA) Reagent, Revised SYN MA 510K_Summary 04.07.09 no LX.doc

August, 2008

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three bars representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Beckman Coulter Inc. c/o Ms. Marine Boyajian Senior Regulatory Affairs Specialist 200, South Kraemer Blvd W-110 Brea, CA 92822-8000

APR - 8 2009

K082251 Re:

Trade/Device Name: SYNCHRON Systems MicroAlbumin (MA) Reagent Regulation Number: 21 CFR 866.5040 Regulation Name: Albumin immunological test system Regulatory Class: Class II Product Code: DCF Dated: March 03, 2009 Received: March 04, 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); 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 a legally 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 (301) 594-3084. Also, please note 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 toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Coy. C. He

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

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Indication for Use

510(k) Number (if known): K082251

Device Name: SYNCHRON® Systems Microalbumin (MA) Reagent

Indication For Use:

MA reagent, when used in conjunction with SYNCHRON CX® System(s) and SYNCHRON CX® MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine. Measurement of albumin in urine aids in the diagnosis of kidney dysfunction.

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 (OIVD)

Division Sig Off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K082251

Regulation Number and Section

§ 866.5040 Albumin immunological test system.

(a)
Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.