The SYNCHRON Systems Hemoglobin A1c (HbA1c) Reagent Kit, in conjunction with SYNCHRON HbA1c Calibrators and SYNCHRON HbA1c Hemolyzing Reagent, is intended for the quantitative determination of Hemoglobin A1c concentrations in whole blood on SYNCHRON Clinical Systems.

Device Description

The SYNCHRON Hemoglobin A1c (HbA1c) Reagent kit contains two reagents, Hb and A1c for determining the Hemoglobin A1c concentrations in whole blood on SYNCHRON Clinical Systems.

AI/ML Overview

Here's an analysis of the provided text regarding the Beckman SYNCHRON Systems Hemoglobin A1c (HbA1c) Reagent, structured according to your requirements:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Note: This document describes an in vitro diagnostic (IVD) reagent, not an AI/ML powered device. Therefore, many of the requested fields (like those pertaining to AI model performance, expert ground truth, MRMC studies, or training sets) are not applicable. I will indicate "N/A" where appropriate and provide relevant information based on the type of device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for slope, intercept, r-value, or imprecision directly. Instead, it presents the results of equivalence studies against a predicate device and a reference method. The "acceptance" is implied by the FDA's substantial equivalence determination, meaning the performance of the new device is comparable to legally marketed devices.

However, we can infer the performance metrics from the results provided:

Performance Metric	Acceptance Criteria (Implied by equivalence)	Reported Device Performance (SYNCHRON HbA1c Reagent)
Method Comparison (vs. Predicate):
Slope	Close to 1.0	0.9906
Intercept	Close to 0.0%	-0.19%
Correlation Coefficient (r)	High (typically > 0.95 for good correlation)	0.9698
Method Comparison (vs. HPLC):
Slope	Close to 1.0	0.9937
Intercept	Close to 0.0%	-0.25%
Correlation Coefficient (r)	High (typically > 0.95 for good correlation)	0.9678
Within-Run Imprecision:	Low %CV for each level	Level 1: 4.5% CV (Mean 6.05% HbA1c)
		Level 2: 3.0% CV (Mean 8.75% HbA1c)
		Level 3: 2.9% CV (Mean 10.73% HbA1c)
Total Imprecision:	Low %CV for each level	Level 1: 7.2% CV (Mean 6.05% HbA1c)
		Level 2: 6.0% CV (Mean 8.75% HbA1c)
		Level 3: 6.9% CV (Mean 10.73% HbA1c)
Stability	Adequate shelf-life and in-use stability	Results not numerically provided in summary

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

The document does not explicitly state the sample sizes for the method comparison studies beyond implying "data" was used. The imprecision study specifies a sample size (N) of 80 for each level tested for both within-run and total imprecision.

Data Provenance: Not specified, but implied to be clinical samples or controls used in laboratory settings for method comparison and imprecision studies. Country of origin not mentioned. The studies appear retrospective in the sense that they are conducted on samples/controls to compare against established methods, not necessarily prospectively collected for this trial alone.

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

N/A. This is an IVD reagent. "Ground truth" for this type of device is established by the results of accepted reference methods or predicate devices, as well as the intrinsic chemical properties and stability of the reagent itself. No human experts are establishing "ground truth" in the way they would for image interpretation or diagnosis.

4. Adjudication Method for the Test Set

N/A. As an IVD reagent, adjudication methods for expert consensus are not applicable. The comparison is quantitative against established methods.

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

N/A. This is an IVD reagent, not an AI/ML powered device. No human readers or AI assistance are involved in the direct output of the device.

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

Yes, in spirit. The performance data (method comparison, imprecision, stability) represent the intrinsic performance of the SYNCHRON HbA1c Reagent system (reagent + SYNCHRON analyzer) operating in a "standalone" fashion to generate a quantitative result. There is no human interpretation or intervention in deriving the numerical output. The human operator's role is in running the test and interpreting the final quantitative value within a clinical context.

7. The Type of Ground Truth Used

For the method comparison studies, the "ground truth" was established by:

The predicate device: Tina-quant® Hemoglobin A1c Assay on a SYNCHRON CX4CE System.
A reference method: Biorad Diamat™ HPLC Hemoglobin A1c Method.

For imprecision studies, the "ground truth" is the true concentration of the assayed control material, against which the variability of repeated measurements is assessed.

8. The Sample Size for the Training Set

N/A. This is an IVD reagent. There is no "training set" in the context of machine learning or AI models. The development and optimization of the reagent formulation and assay parameters would involve internal R&D studies, but these are not referred to as "training sets" in this context.

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

N/A. See point 8.

Summary

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K973696

Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON Systems Hemoglobin A1c (HbA1c) Reagent Summary of Safety & Effectiveness

NOV

Summary of Safety & Effectiveness Beckman SYNCHRON® Systems Hemoglobin A1c Reagent

1.0 Submitted Bv:

Lucinda Stockert Senior Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4457

2.0 Date Submitted:

24 September 1997

3.0 Device Name(s):

3.1 Proprietary Names

SYNCHRON® Systems Hemoglobin A1c (HbA1c) Reagent

3.2 Classification Name

Glycosylated hemoglobin assay (21 CFR § 864.7470)

4.0 Predicate Device(s):

BECKMAN Reagent	Predicate	Predicate Company	Docket Number
SYNCHRON SystemsHemoglobin A1c	Tina-quant®Hemoglobin A1cAssay	Boehringer MannheimCorporation	K934070

5.0 Description:

The SYNCHRON Hemoglobin A1c (HbA1c) Reagent kit contains two reagents, Hb and A1c for determining the Hemoglobin A1c concentrations in whole blood on SYNCHRON Clinical Systems.

6.0 Intended Use:

The SYNCHRON Hemoglobin A1c (HbA1c) Reagent kit, in conjunction with the SYNCHRON Hemoglobin A1c Calibrators, is intended for the quantitative determination of hemoglobin A1c concentration as a percentage of total hemoglobin in whole blood on SYNCHRON Systems.

7.0 Comparison to Predicate(s):

The following tables show similarities and differences between the predicate identified in Section 4.0 of this summary.

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Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON Systems Hemoglobin A1c (HbA1c) Reagent Summary of Safety & Effectiveness

Reagent	Aspect/Characteristic	Comments
	SIMILARITIES
SYNCHRONSystems HemoglobinA1c(HbA1c)Reagent	Intended use	Same as the predicate
	Formulation	Same source, processing as predicate
	Chemical Reaction	Same principle as the predicate
	Sample Preparation	Same as the predicate
	Calibration	Same as the predicate
	Reagent Kit Configuration	Same as the predicate
	DIFFERENCES
SYNCHRON SystemsHemoglobin A1c(HbA1c)Reagent	Assay parameters	SYNCHRON parameters reside in theSYNCHRON database, BMCparameters must be operatorprogrammed
	Cartridges	Cartridges bar-coded specifically forSYNCHRON HbA1c vs non bar-codedcartridges with BMC reagent

Summary of Performance Data: 8.0

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, stability, and imprecision experiments that relate results obtained from the SYNCHRON HbA1c Reagent to the Boehringer Mannheim Tina-quant® Hemoglobin A1c assay.

Method Companison Study Results

Analyte	Slope	Intercept	r	Predicate Method
SYNCHRONHemoglobin A1c(HbA1c)Reagent	0.9906	-0.19%	0.9698	Boehringer MannheimHemoglobin A1c Reagent onSYNCHRON CX4CE System
Reagent	0.9937	-0.25%	0.9678	Biorad DiamatTM HPLCHemoglobin A1c Method

Stability Study Results

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------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ANNUAL AND COLORIAL COLLEGIAN--------------------------------------	1 100 11 11 15 15 15 15 15 15 15 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11RECENTRAL II LANDARIES OF LEASTER CONSULTION OFAND CORPARA CORPORATION OF COLLECTION OF
Comments of the contraction of the contribution of the commend of the commend of the commend of the many of the many of the many of the many of the many of the many of the ma.	11 18 1 1 8 8 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1

Estimated SYNCHRON HbA1c Reagent Imprecision

Sample	Mean (%HbA1c)	S.D. (%)	%C.V.	N
Within-Run Imprecision
Level 1	6.05	0.27	4.5	80
Level 2	8.75	0.26	3.0	80
Level 3	10.73	0.31	2.9	80
Total Imprecision
Level 1	6.05	0.44	7.2	80
Level 2	8.75	0.52	6.0	80
Level 3	10.73	0.74	6.9	80

The Summary of Safety and Effectiveness information for the SYNCHRON Systems HbA1c Reagents 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.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a bird in flight. The logo is presented in black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 2 4 1997

Lucinda Stockert Senior Regulatory Specialist Beckman Instruments, Inc. 200 S. Kraemer Boulevard, M/S W-337 P.O. Box 800 Brea, California 92822-8000

Re: K973696 Synchron® Systems Hemoglobin A1c (HbA1c) Reagent Regulatory Class :... II . .............................. Product Code: LCP September 24, 1997 Dated: Received: September 26, 1997

Dear Ms. Stockert:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:

this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (CHIA-68), Chila device may require if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as Inis leccer will aremarket notification. The FDA described in your sio\n privalence of your device to a legally marketed predicate device results in a classification for your marketed produces 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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Victo diagnoBele develop, productionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general premarket notification" (21 CFR 807.97). information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obeathed from onember (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

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

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K973696

510(k) Number (if known): Not yet assigned

SYNCHRON® Systems Hemoglobin A1c Reagent Device Name:

Indications for Use:

21 CFR 864.7470 Glycosylated hemoglobin assay

(a) Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a, A1b, A1c) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

(b) Classification. Class II.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number	2973696
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Prescription Use (per 21 CFR 801.109)	Over-the-Counter Use Optional Format 1-2-96
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Regulation Number and Section

§ 864.7470 Glycosylated hemoglobin assay.

(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).