The SYNCHRON MULTI CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate, Magnesium, Total Protein, Triglycerides, and Uric Acid.

Device Description

This is a liquid, ready-to-use, multi analyte, IVD calibrator. The SYNCHRON Multi Calibrator is prepared in a human serum matrix which is stabilized by the use of ethylene glycol. During manufacture, the multiple constituents are spiked into the matrix at the desired concentration levels. The analyte(s) in this calibrator is traceable using prEN ISO 17511 to the reference materials listed below.

AI/ML Overview

The provided document is a 510(k) summary for the SYNCHRON® Systems SYNCHRON Multi Calibrator. This device is a multi-analyte IVD calibrator. The document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria in the typical sense of a diagnostic test's accuracy, sensitivity, or specificity.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission for a calibrator.

However, I can extract information related to the device's technical specifications and the comparison to its predicate.

Here's the information that can be extracted and how it relates to "acceptance criteria" for a calibrator in this context:

1. A table of acceptance criteria and the reported device performance

For a calibrator, "performance" is demonstrated by its inherent properties, traceability, value assignment, and stability, rather than clinical performance metrics. The acceptance criteria essentially stem from being substantially equivalent to the predicate and meeting established traceability standards.

Acceptance Criteria (Implied by Regulatory Submission)	Reported Device Performance (Provided in document)
Intended Use: Calibration of specific analytes on SYNCHRON Systems.	The SYNCHRON MULTI CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate, Magnesium, Total Protein, Triglycerides, and Uric Acid. This is comparable to the predicate's intended use for similar analytes.
Matrix base: Human serum, stabilized with ethylene glycol.	The calibrator is prepared from human serum and stabilized by the use of ethylene glycol. (Identical to predicate).
Levels: Single level calibrator.	1 (Identical to predicate).
Form: Liquid, ready to use.	Liquid, ready to use (Identical to predicate).
Open vial stability: 20 days at +2°C to +8°C.	20 days at +2°C to +8°C (Identical to predicate).
Storage: -15°C to -20°C.	-15°C to -20°C (Identical to predicate).
Packaging: 6 X 20 mL bottles.	6 X 20 mL bottles (Identical to predicate).
Real time stability: 24 months.	24 months (Identical to predicate).
Traceability: Analytes are traceable to recognized reference materials.	Analytes are traceable using prEN ISO 17511 to reference materials such as NIST 927a (ALB, TP), NIST SRM 915 (CA), NIST 911b (CHOL), NIST SRM 917a (GLU), NIST SRM 929 (MG), NIST SRM 3139a (PHOS, PHS, PO4), NIST SRM 912a (UREA, BUN), and NIST SRM 913b (URIC). Lactate and TG/TG-B are traceable to manufacturer's working calibrator.
Value Assignment: Values are assigned and stability data is available.	"Value assignment and stability data is available with Beckman Coulter." (Summary statement; specific data not provided in the public summary). The summary states "Equivalence is demonstrated through device comparisons, traceability information, value assignment practices and stability experiments."
Substantial Equivalence: Demonstrate equivalence to the predicate device.	The FDA determined the device is substantially equivalent to the predicate device K883181. This is based on the similarities outlined in the comparison tables and the summary performance data.
Inclusion/Exclusion of Analytes: The new calibrator may have a modified panel of value-assigned analytes compared to the predicate, provided equivalence is still shown.	The proposed device includes Lactate and Magnesium as value-assigned analytes, which were not value-assigned in the predicate's intended use. It removes Creatinine. (This difference is acceptable within the context of substantial equivalence if performance is still demonstrated).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. For a calibrator, "test set" would typically refer to samples analyzed during studies for value assignment, linearity, stability, and comparison to reference materials. The document only states that "Value assignment and stability data is available with Beckman Coulter" and that "Equivalence is demonstrated through device comparisons, traceability information, value assignment practices and stability experiments." Specific details on sample sizes or data provenance are not public in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable/not provided for a device like a calibrator. Ground truth for a calibrator is established through metrological traceability to reference materials and robust analytical methods, not expert consensus in the same way as, for example, an imaging diagnostic.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable/not provided for this type of device.

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

This is not applicable. This is an in vitro diagnostic calibrator, not a diagnostic imaging device with human readers.

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

This is not applicable in the context of an "algorithm only" performance for this device. Its performance is inherent to its physical and chemical properties and its interaction with the SYNCHRON Systems for calibration.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the analytes in the calibrator, the "ground truth" (or reference values) is established through traceability to internationally recognized reference materials, primarily the National Institute of Standards and Technology (NIST) Standard Reference Materials (SRMs), and the manufacturer's working calibrators where NIST SRMs are not directly available (e.g., Lactate, TG, TG-B). This is a metrological ground truth derived from certified reference materials.

8. The sample size for the training set

This is not provided and is generally not applicable for a calibrator in the same way it would be for an AI/ML algorithm. The "training" for a calibrator involves its manufacturing process, value assignment, and stability testing.

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

Similar to point 7, the "ground truth" for value assignment in the manufacturing and testing of the calibrator is established through metrological traceability to NIST SRMs and manufacturer's working calibrators, following standards like prEN ISO 17511. This involves analytical measurement against higher-order reference materials and/or methods. The specific protocols for this are proprietary to Beckman Coulter but must adhere to regulatory guidelines.

Summary

{0}------------------------------------------------

K 110251

MAY 2 5 2011

Image /page/0/Picture/2 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic to the left of the company name. The graphic contains two curved lines that are parallel to each other. The text "BECKMAN COULTER" is to the right of the graphic, with "BECKMAN" on the top line and "COULTER" on the bottom line.

Summary of Safety & Effectiveness SYNCHRON® Systems SYNCHRON Multi Calibrator

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.

1.0 Submitted By:

Yvette Lloyd, JD Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 250 S. Kraemer Blvd Mail Stop: E2.SE.08 Brea, CA 92821 Phone: (714) 961-3626 FAX: (714) 961-4234 email: yrlloyd@beckman.com

2.0 Date Submitted:

January 26, 2011 and May 5, 2011

3.0 Device Name(s):

3.1 Proprietary Names SYNCHRON Multi Calibrator

3.2 Classification Name

Calibrator, Secondary or Multi-Analyte Mixture (Product Code - JIT/JIX), 21 CFR.1150, Class II, (75)

4.0 Predicate Device:

Candidate(s)	Predicate	Manufacturer	DocketNumber
SYNCHRON Multi Calibrator	SYNCHRON MultiCalibrator	Beckman	K883181

Mailing Address: 250 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000

{1}------------------------------------------------

5.0 Description:

Measurand	Traceable To
ALB	NIST 927a'
CA	NIST SRM 915
CHOL	NIST 911b
GLU	NIST SRM 917a
Lactate	Manufacturer's working calibrator
MG	NIST SRM 929
PHOS	NIST SRM 3139a
PHS	NIST SRM 3139a
PO4	NIST SRM 3139a
TP	NIST SRM 927a
TG, TG-B	Manufacturer's working calibrator
UREA	NIST SRM 912a
BUN	NIST SRM 912a
URIC	NIST SRM 913b

Value assignment and stability data is available with Beckman Coulter.

6.0 Intended Use:

7.0 Comparison to Predicate(s):

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

	Predicate Device: SYNCHRON Multi Calibrator	Proposed Device: SYNCHRON Multi Calibrator
Intended Use	The Beckman CX MULTI CALIBRATOR, inconjunction with SYNCHRON CX reagents, isintended for use on SYNCHRON CX4 and CX5Systems for the calibration of Albumin, Blood UreaNitrogen (Urea), Calcium, Cholesterol, Creatinine,Glucose, Inorganic Phosphorus, Total Protein,Triglycerides, and Uric Acid.	The SYNCHRON MULTI CALIBRATOR, used inconjunction with SYNCHRON reagents, is intended foruse on SYNCHRON Systems for the calibration ofAlbumin, Blood Urea Nitrogen (Urea), Calcium,Cholesterol, Glucose, Inorganic Phosphorus, Lactate,Magnesium, Total Protein, Triglycerides, and Uric Acid.
Matrix base	The calibrator is prepared from human serum andstabilized by the use of ethylene glycol.	The calibrator is prepared from human serum andstabilized by the use of ethylene glycol.
Levels	1	1
Form	Liquid, ready to use	Liquid, ready to use
Open vial stability	20 days at +2°C to +8°C	20 days at +2°C to +8°C
Storage	-15°C to -20°C	-15°C to -20°C
Packaging	6 X 20 mL bottles	6 X 20 mL bottles
Real time stability	24 months	24 months

List of design inputs that are the same between the two devices

Beckman Coulter, Inc. 250 S. Kraemer Boulevard Brea, CA 92821

Mailing Address: 250 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000

Telephone: (714) 993-5321 Facsimile: (714) 961-4165 Internet: www.beckmancoulter.com

{2}------------------------------------------------

Differences	Predicate Device: SYNCHRON MultiCalibrator	Proposed Device: SYNCHRON MultiCalibrator
Value assignedanalytes	Albumin, Blood Urea Nitrogen (Urea), Calcium,Cholesterol, Creatinine, Glucose, InorganicPhosphorus, Total Protein, Triglycerides, andUric Acid.	Albumin, Blood Urea Nitrogen (Urea), Calcium,Cholesterol, Glucose, Inorganic Phosphorus,Lactate, Magnesium, Total Protein,Triglycerides, and Uric Acid.
Formulation:Multipleconstituents	Albumin, Blood Urea Nitrogen (Urea), Calcium,Cholesterol, Creatinine, Glucose, InorganicPhosphorus, Lactate, Magnesium, TotalProtein, Triglycerides, Uric Acid and Iron (notvalue assigned).	Albumin, Blood Urea Nitrogen (Urea), Calcium,Cholesterol, Glucose, Inorganic Phosphorus,Lactate, Magnesium, Total Protein,Triglycerides, and Uric Acid; Includes also,Creatinine, Iron, Salicylate and AlkalinePhosphatase (not value assigned analytes).

List of design inputs that are different between the two devices

8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to the predicate which is an existing multi calibrator already in commercial distribution with well established use and robustness. Equivalence is demonstrated through device comparisons, traceability information, value assignment practices and stability experiments.

Mailing Address: 250 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000

Telephone: (714) 993-5321 Facsimile: (714) 961-4165 Internet: www.beckmancoulter.com

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or other bird with its wings spread.

Public Health Service

Beckman Coulter, Inc. c/o Yvette Lloyd 250 S. Kraemer Blvd., Mail Stop: E2.SE.08 Brea, CA 92821

Re: K110251

Trade/Device Name: SYNCHRON Systems SYNCHRON Multi Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator, Multi-Analyte Mixture Regulatory Class: Class II Product Code: JIX MAY 2 5 2011 Dated: 13 Apr 2011 Received: 15 Apr 2011

Dear: Ms. Lloyd,

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), 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). 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.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

{4}------------------------------------------------

Page 2 –

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation (21 CPN Paul Sull (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

C.C.

Courmey Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

:沙

Enclosure

{5}------------------------------------------------

Attachment A:

Indications for Use Form

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ___ SYNCHRON® Systems SYNCHRON MULTI CALIBRATOR

Indications for Use:

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the commen

Qus

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

510(k) ie 11025

Page 1 of 1

SYNCHRON Multi Calibrator Section 510(k) Supplemental Information, K110251 (Supp1)_04132011 11

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(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 the limitations in § 862.9.