SYNCHRON® Systems HDL Cholesterol (HDLD) Reagent, when used in conjunction with SYNCHRON® Systems Lipid Calibrator, is intended for the quantitative determination of HDL cholesterol in the high-density lipoprotein (HDL) fraction of serum or plasma on SYNCHRON Systems.

Device Description

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the SYNCHRON® Systems HDL Cholesterol (HDLD) Reagent:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary document for K040767 does not explicitly state pre-defined acceptance criteria for the "Method Comparison Study Results" in terms of specific thresholds for slope, intercept, or correlation coefficient (r). Instead, it presents the results from a comparison to a predicate device and implies that these results demonstrate substantial equivalence.

However, based on standard expectations for method comparison studies in clinical chemistry, the "acceptance criteria" can be inferred based on what is generally considered acceptable for demonstrating equivalence. The reported performance is directly from the document.

Metric	Inferred Acceptance Criteria (Typical)	Reported Device Performance (SYNCHRON® Systems HDLD Reagent)
Method Comparison
Slope	Ideally close to 1.0 (e.g., within 0.95-1.05 or similar range, depends on assay and clinical impact)	SYNCHRON CX: 0.991 SYNCHRON LX: 0.973
Intercept	Ideally close to 0.0 (e.g., within a predefined range, depends on assay and clinical impact)	SYNCHRON CX: 2.2 SYNCHRON LX: 0.5
Correlation (r)	Ideally > 0.975 - 0.98 (often >0.95 or higher, depending on the assay and clinical impact)	SYNCHRON CX: 0.956 SYNCHRON LX: 0.972
N (Sample Size)	Sufficiently large to provide statistical power (e.g., usually >40, 60, or 100 samples are common)	SYNCHRON CX: 63 SYNCHRON LX: 66

Note: The "Inferred Acceptance Criteria" are based on common industry practices for method validation and are not explicitly stated as pass/fail criteria in the provided text. The document states "Equivalence is demonstrated through method comparison, stability, linearity, and imprecision experiments," implying that these results were deemed acceptable by the manufacturer and FDA.

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

Sample Size for the Test Set:
- SYNCHRON CX Comparison: 63 samples (n=63)
- SYNCHRON LX Comparison: 66 samples (n=66)
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions the "Method Comparison Study Results."

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

This information is not provided in the given text. For an in vitro diagnostic (IVD) device like an HDL cholesterol reagent, the "ground truth" for a method comparison is typically established by comparing the results of the new method to a well-established, often FDA-cleared, predicate method (or a reference method). In this case, the SYNCHRON HDLC method serves as the comparison method, not human expert interpretation.

4. Adjudication Method for the Test Set

This concept of "adjudication" is typically relevant for studies where subjective interpretation is involved (e.g., medical imaging or pathology). For a quantitative chemical assay, adjudication is not applicable in the same way. The comparison is between two quantitative measurements.

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. An MRMC study is relevant for devices that involve human interpretation, often aided by AI. This device is a quantitative chemical reagent where the output is a numerical value, not an image or complex data needing human interpretation. No AI component is mentioned.

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

The device itself is a standalone diagnostic reagent system for quantitative measurement. Its performance described in the method comparison is inherently "standalone" in the sense that it produces a result directly from a sample without human interpretive intervention. There is no "algorithm" in the context of AI being evaluated here; it's a chemical assay.

7. The Type of Ground Truth Used

For the method comparison study, the "ground truth" (or reference standard for comparison) used was the SYNCHRON HDLC method, which is a previously cleared and established method for HDL cholesterol determination by Beckman Coulter, Inc. (K934045). This is an example of comparing to an existing
predicate device performance.

8. The Sample Size for the Training Set

This information is not provided. The document focuses on performance data for the commercialization of the device, with existing predicate data likely used for initial development and validation. The concept of a "training set" is more commonly associated with machine learning algorithms, which are not applicable here. However, similar to a training set, the initial development and optimization of the reagent involved a larger set of samples and experiments, but these are not distinctively labeled in this summary.

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

Since there is no "training set" explicitly identified in the context of a machine learning algorithm, and the device is a chemical reagent, this question is not applicable in the way it's phrased. Development of chemical assays relies on validated reference methods and analytical techniques to establish accuracy, linearity, and precision during the research and development phase. If we consider the predicate device (SYNCHRON HDLC) as a "ground truth" reference against which this new reagent was developed or compared, its ground truth would have been established through its own validation studies, likely including comparison to a definitive method (e.g., CDC reference method for cholesterol).

Summary

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K040767

JUN = 7 2004

510(k) Summary SYNCHRON® Systems HDL Cholesterol Reagent

1.0 Submitted By:

Annette Hellie Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4123

2.0 Date Submitted:

March 24, 2004

3.0 Device Name(s):

3.1 Proprietary Names

SYNCHRON® Systems HDL Cholesterol (HDLD) Reagent

3.2 Classification Name

Lipoprotein test system (21 CFR § 862.1475)

4.0 Predicate Device:

Candidate(s)	Predicate	Manufacturer	DocketNumber
SYNCHRONSystemsHDLD Reagent	SYNCHRON SystemsHDLD Reagent	BeckmanCoulter, Inc.	K934045

5.0 Description:

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6.0 Intended Use:

Clinical Significance:

7.0 Comparison to Predicate(s):

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

	Similarities
HDLD Reagent	Intended Use	Same asHDLC
	Liquid stable reagent
	Differences
HDLD Reagent	Methodology	HDLC is an indirect method, HDLD is adirect method
	Analytic Range	HDLC = 5 to 90 mg/dLHDLD = 5 to 135 mg/dL

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 Equivalence is demonstrated through method commercial distribution. comparison, stability, linearity, and imprecision experiments.

Method Comparison Study Results

Instrument	Slope	Intercept	r	n	Comparison Method
SYNCHRON CX	0.991	2.2	0.956	63	SYNCHRON HDLC
SYNCHRON LX	0.973	0.5	0.972	66	SYNCHRON HDLC

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

JUN - 7 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Annette Hellie Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 South Kraemer Blvd. PO Box 8000 Brea, CA 92821

Re: K040767

K040107
Trade/Device Name: SYNCHRON® Systems HDL Cholesterol (HDLD) Reagent Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: LBS Dated: March 24, 2004 Received: March 25, 2004

Dear Ms. Hellie:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications ferenced abo re and hansure) to legally marketed predicate devices marketed in interstate for association to May 28, 1976, the enactment date of the Medical Device Amendments, or to eonimores 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 I ou may, ates or visions 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 it may of subject to data and 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 r loase be advisou that i Dr unation that your device complies with other requirements of the Act that I Dr has intatutes and regulations administered by other Federal agencies. You must of any I oderal batates and sequirements, 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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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and will be reading of substantial equivalence of your device to a legally premaince notifications of 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, If you destions on the promotion and advertising of your device, please contact the Office of or questions on the Presidention 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 rou may obtain other getarers, 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,

Jean M. Cooper, MS, DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K0 407 (ø7

Device Name: SYNCHRON® Systems HDL Cholesterol (HDLD) Reagent

Indications for Use:

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

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

Alberto Lutz
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510(k) K040767

Regulation Number and Section

§ 862.1475 Lipoprotein test system.

(a)
Identification. 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 (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.