UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator by BECKMAN COULTER, INC.

Reagent: UniCel DxC SYNCHRON Systems HDL Cholesterol reagent (HDL), when used in conjunction with UniCel DxC 600/800 SYNCHRON System(s) and UniCel DxC SYNCHRON Systems HDL Calibrator, is intended for quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders mellitus), atherosclerosis, and various liver and renal diseases.

Calibrator: The UniCel DxC SYNCHRON Systems HDL Calibrator is designed to provide suitable calibration levels for Beckman Coulter UniCel DxC 600/800 SYNCHRON Systems employing the quantitative UniCel DxC SYNCHRON Systems HDL Cholesterol reagent (HDL).

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification for in vitro diagnostic devices (UniCel DxC SYNCHRON Systems HDL Cholesterol Reagent and Calibrator), not an AI/ML medical device. Therefore, many of the requested criteria regarding AI model performance, ground truth, experts, and training/test sets are not applicable or typically documented in this type of submission.

However, I can extract and present information relevant to device performance and substantiation that is typically found in such a document for an IVD.

Here's an interpretation based on the provided text, acknowledging the limitations for an IVD device:

Device: UniCel DxC SYNCHRON Systems HDL Cholesterol Reagent (HDL) and UniCel DxC SYNCHRON Systems HDL Calibrator.
Intended Use: Quantitative determination of HDL cholesterol in the high density lipoprotein fraction of human serum or plasma.

1. Table of Acceptance Criteria and Reported Device Performance

For an IVD such as this, "acceptance criteria" and "device performance" typically refer to analytical performance characteristics demonstrated through validation studies (e.g., accuracy, precision, linearity, interference, method comparison). While the provided 510(k) summary (which is typically a brief overview) doesn't contain a detailed table of specific criteria and results, it implies that performance data was submitted and found acceptable for substantial equivalence to a predicate device.

To illustrate, here's a hypothetical table based on common IVD performance metrics that would be assessed for a device like this, as the actual data is not present in the provided snippet:

Performance Characteristic	Acceptance Criteria (Hypothetical)	Reported Device Performance (Hypothetical / Implied)
Accuracy (Method Comparison)	Correlation (r) ≥ 0.95 vs. Predicate or Reference Method	Implied to meet or exceed; not explicitly stated.
Bias	Bias ≤ 5% at medical decision points	Implied to meet or exceed; not explicitly stated.
Precision (Within-run, Total)	%CV ≤ 5% at medical decision points	Implied to meet or exceed; not explicitly stated.
Linearity	Linear throughout the reportable range	Implied to meet or exceed; not explicitly stated.
Interference	No significant interference from common interferents	Implied to meet or exceed; not explicitly stated.

Note: The FDA's issuance of a determination of substantial equivalence (as stated in the letter) means that sufficient data was provided to demonstrate the device performs as intended and is as safe and effective as a legally marketed predicate device. This data would include studies addressing the above performance characteristics.

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

The provided text from the 510(k) notification does not specify the sample size for any test set or the provenance of the data. For IVD devices, clinical samples (serum/plasma), control materials, and calibrators are used in analytical validation studies. These studies are typically conducted by the manufacturer, often at multiple sites (laboratories), and typically use samples from diverse populations to ensure generalizability. The studies would be considered prospective in terms of data collection for the specific validation protocols.

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

This question is not applicable to an in vitro diagnostic reagent and calibrator like the one described. "Ground truth" in the context of an AI/ML medical device typically refers to expert annotations or conclusive diagnoses. For an IVD, the "ground truth" for evaluating performance would be established by:

Reference Methods: Using a well-established, often CDC-certified or industry-standard reference method for HDL cholesterol measurement, which may itself involve highly skilled laboratory professionals.
Certified Reference Materials: Using materials with established true values (e.g., NIST traceable materials).

The performance of the device is assessed against these established methods or materials, not against expert consensus on images or similar diagnostic interpretations.

4. Adjudication Method for the Test Set

This concept is not typically applicable to the validation of an IVD reagent and calibrator. Adjudication methods (like 2+1 or 3+1) are used in AI/ML performance studies where multiple human experts individually assess a case, and discrepancies are resolved. For an IVD, analytical results are quantitative and compared against established methods or values, not adjudicated expert opinions.

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 question is not applicable. MRMC studies are used to evaluate the diagnostic accuracy of imaging devices or AI algorithms (often with human readers). This device is a quantitative a chemical reagent and calibrator for an automated laboratory system, not an imaging device or an AI diagnostic tool that assists human readers in interpretation.

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

This question is not applicable. The device is a chemical reagent and calibrator system used on an automated analyzer (UniCel DxC 600/800 SYNCHRON System). Its performance is inherently "standalone" in the sense that the instrument processes the sample and yields a quantitative result without direct "human-in-the-loop" interpretation for each test result in the way an AI diagnostic tool might require. The "algorithm" here is the chemical reaction and photometric measurement, not a computational AI model.

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

For this IVD, the "ground truth" would be established by:

Reference Measurement Procedures: Highly accurate and precise laboratory methods (e.g., CDC reference methods) for determining HDL cholesterol levels in samples.
Certified Reference Materials: Materials with an accurately assigned value for HDL cholesterol.

Essentially, it's a comparison to established, highly accurate analytical methods rather than subjective expert consensus or pathology.

8. The sample size for the training set

This question is not applicable. This device is not an AI/ML model that requires a "training set" in the computational sense. The reagents are developed and optimized through chemical formulation and analytical studies, not statistical model training.

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

This question is not applicable, as there is no "training set" in the AI/ML context for this type of IVD device. The "ground truth" (reference values) established for validation studies (as in #7) would be used to assess the accuracy and performance of the finalized reagent and calibrator system.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 26, 2015

BECKMAN COULTER, INC. C/O EIMEAR CARR REGULATORY AFFAIRS SPECIALIST 250 S. KREAMER BOULEVARD BREA CA 92821

Re: K142985

Trade/Device Name: UniCel DxC SYNCHRON Systems HDL Cholesterol Reagent (HDL) Unicel Dxc SYNCHRON Systems HDL Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT, LBS Dated: January 23, 2015 Received: January 27, 2015

Dear Eimear Carr:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Katherine Serrano -A

For :Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

UniCel DxC SYNCHRON Systems HDL Cholesterol reagent (HDL) UniCel DxC SYNCHRON Systems HDL Calibrator

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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.