HDLX reagent, when used in conjunction with SYNCHRON LX® System(s), UniCel® DxC 800 System(s) and Genzyme Liquid N-geneous® HDL Cholesterol Calibrator is intended for quantitative determination of HDL Cholesterol in the high density lipoprotein fraction of human serum or plasma.

HDL cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases, and for the assessment of the risk of developing cardiovascular disease.

Device Description

This direct HDL Cholesterol method is a homogeneous assay without the need for any offline pretreatment or centrifugation steps. The method depends on a unique detergent which solubilizes only the HDL lipoprotein particles and releases HDL cholesterol to react with cholesterol esterase and cholesterol oxidase in the presence of chromogens, to produce a color product. The same detergent also inhibits the reaction of the cholesterol enzymes with LDL, VLDL, and chylomicrons lipoproteins by adsorbing to their surfaces. A polyanion contained in the reagent enhances the selectivity for HDL cholesterol assay by complexing LDL, VLDL, and chylomicrons lipoproteins.

HDLX reagent is used to measure the cholesterol concentration by a timed-endpoint method. The SYNCHRON® System(s) automatically proportions the appropriate HDL cholesterol sample and reagent volumes into a cuvette. The ratio used is one part sample to 93 parts reagent. The System monitors the change in absorbance at 560 nanometers. This change in absorbance is directly proportional to the concentration of cholesterol in the sample and is used by the System to calculate and express the HDL-cholesterol concentration.

AI/ML Overview

{
  "1_table_of_acceptance_criteria_and_reported_device_performance": {
    "Method Comparison Study (vs. Olympus HDLX Assay)": {
      "Platform": [
        "UniCel DxC 800",
        "LX20"
      ],
      "Acceptance Criteria (implicit based on R value)": [
        "High correlation (R near 1)"
      ],
      "Reported Device Performance": [
        "R = 0.991",
        "R = 0.984"
      ]
    },
    "Precision Study (Within-Run Imprecision)": {
      "Platform and Sample": [
        "UniCel DxC 800 - SYN 1",
        "UniCel DxC 800 - SYN 2",
        "UniCel DxC 800 - SYN 3",
        "UniCel DxC 800 - Vigil Lipid 1",
        "UniCel DxC 800 - Vigil Lipid 2",
        "UniCel DxC 800 - Vigil Lipid 4",
        "LX20 - SYN 1",
        "LX20 - SYN 2",
        "LX20 - SYN 3",
        "LX20 - Vigil Lipid 1",
        "LX20 - Vigil Lipid 2",
        "LX20 - Vigil Lipid 4"
      ],
      "Acceptance Criteria (implicit based on %C.V.)": [
        "Low imprecision (low %C.V.)"
      ],
      "Reported Device Performance (%C.V.)": [
        "1.66",
        "0.85",
        "0.82",
        "1.83",
        "1.13",
        "0.85",
        "1.05",
        "0.77",
        "0.87",
        "1.64",
        "1.33",
        "1.39"
      ]
    }
  },
  "2_sample_size_and_data_provenance": {
    "Method Comparison Study": {
      "Sample Size (Test Set)": "100 samples for each platform (UniCel DxC 800 and LX20)",
      "Data Provenance": "Not specified (retrospective or prospective, country of origin not mentioned in the provided text)."
    },
    "Precision Study (Within-Run Imprecision)": {
      "Sample Size (Test Set)": "20 replicates for each of 6 samples on each platform (UniCel DxC 800 and LX20), totaling 240 measurements (20 * 6 * 2).",
      "Data Provenance": "Not specified (retrospective or prospective, country of origin not mentioned in the provided text)."
    }
  },
  "3_number_of_experts_and_qualifications_for_ground_truth": "Not applicable. This device is a diagnostic reagent for quantitative determination, not an imaging or diagnostic interpretation device requiring expert ground truth for classification.",
  "4_adjudication_method": "Not applicable. This device is a diagnostic reagent for quantitative determination, not an imaging or diagnostic interpretation device requiring adjudication.",
  "5_mrmc_comparative_effectiveness_study": "No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This is a diagnostic reagent, not an AI-assisted interpretation device for human readers.",
  "6_standalone_performance_done": "Yes, standalone performance was done for both method comparison and precision studies. The studies compare the device's performance against a predicate device and evaluate its consistency.",
  "7_type_of_ground_truth_used": {
    "Method Comparison Study": "The 'ground truth' was established by the predicate method, the Olympus HDLX Assay ([K040692](https://510k.innolitics.com/search/K040692)). The study aims to demonstrate substantial equivalence to this legally marketed device.",
    "Precision Study": "The 'ground truth' is the quantitative measurement itself, assessed for its consistency and reliability (imprecision). There isn't an external 'ground truth' in the same sense as a diagnostic gold standard; rather, it measures the inherent reproducibility of the device."
  },
  "8_sample_size_for_training_set": "Not applicable/Not specified. This document describes a medical device (a diagnostic reagent) and its validation, not an AI model requiring a training set in the conventional sense.",
  "9_how_ground_truth_for_training_set_was_established": "Not applicable. This document describes a medical device (a diagnostic reagent) and its validation, not an AI model requiring a training set in the conventional sense."
}

Summary

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K.000010

Summary of Safety & Effectiveness SYNCHRON® Systems HDL Cholesterol (HDLX) Reagent

1.0 Submitted By:

MAY 1 4 2010

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

2.0 Date Submitted:

December 18, 2009

3.0 Device Name(s):

3.1 Proprietary Names SYNCHRON® Systems HDL Cholesterol (HDLX) Reagent
3.2 Classification Name
- LDL & VLDL precipitation, Cholesterol via esterase-oxidase, HDL (Product . Code - LBS; 21 CFR § 862.1475)

4.0 Predicate Device:

Candidate(s)	Predicate	Manufacturer	DocketNumber
SYNCHRON® Systems HDLCholesterol (HDLX) Reagent	Olympus HDL CholesterolAssay	OLYMPUSAMERICA,INC.	K040692

5.0 Description:

Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON® Systems HDL Cholesterol (HDLX) Reagent SYN HDLD 510K_Summary_revised_05112010.doc 18-Dec-09

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

6.0 Intended Use:

HDLX reagent, when used in conjunction with SYNCHRON LX® System(s), UniCel® DxC 800 System(s) and Genzyme Liquid N-qeneous® HDL Cholesterol Calibrator is intended for quantitative determination of HDL Cholesterol in the high density lipoprotein fraction of human serum or plasma.

Indications for Use:

7.0 Comparison to Predicate(s):

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

Predicate Device: Olympus HDL CholesterolAssay	Current device: SYNCHRON® SystemsHDL Cholesterol (HDLX) Reagent
LIQUID stable reagents (ready to use)	same
Intended Use	same
Clinical Significance	same
Fundamental Technology: chromogenic coloredchange measured by spectrophotometer	same
Sample Types: Serum, Plasma (Heparinized,EDTA)	same
Reference Interval	same

List of design inputs that are similar between the two devices

List of design inputs that are different between the two devices

List of design inputs that are different between the two devices
	Predicate Device: Olympus HDLCholesterol Assay	Current device: SYNCHRON® Systems HDLCholesterol (HDLX) Reagent
AnalyticalRange	2.5 - 200 mg/dL	5 - 135 mg/dL
Interferingsubstances	Hemoglobin: 500 mg/dLUnconjugated Bilirubin: 40 mg/dLConjugated Bilirubin: 40 mg/dLLipemia: ≤ 1500 mg/dL (Intralipid)Triglyceride: ≤ 900 mg/dL (triglyceride)Ascorbic Acid: 20 mg/dLImmunoglobulin IgG: 5000 mg/dL	Hemoglobin: 500 mg/dLBilirubin: 30 mg/dLLipemia: ≤ 1700 mg/dL (triglyceride)Ascorbic Acid: 50 mg/dLImmunoglobulin IgG: 3000 mg/dL
Sensitivity	Typical change in absorbency for 1 mg/dLof HDL-Cholesterol is 1 mA	5 mg/dL

Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON® Systems HDL Cholesterol (HDLX) Reagent SYN HDLD 510K_Summary_revised_05112010.doc 18-Dec-09

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

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.

Candidate	Platform	Slope	Intercept	R	N	Predicate Method
SYNCHRONSystems HDLCholesterol(HDLX)	UniCel DxC800	1.06	-4.9	0.991	100	Olympus HDLXAssay (K040692)
SYNCHRONSystems HDLCholesterol(HDLX)	LX20	1.06	-5.5	0.984	100	Olympus HDLXAssay (K040692)

Method Comparison Study Results

SYNCHRON® Systems HDL Cholesterol (HDLX) Reagent Precision Study Results

Sample	Mean(mg/dL)	S.D.(mg/dL)	%C.V.	N
Within-Run Imprecision - DxC 800
SYN 1	31.82	0.53	1.66	20
SYN 2	46.56	0.39	0.85	20
SYN 3	62.33	0.51	0.82	20
Vigil Lipid 1	20.20	0.37	1.83	20
Vigil Lipid 2	57.63	0.65	1.13	20
Vigil Lipid 4	98.75	0.84	0.85	20
Within-Run Imprecision - LX20
SYN 1	33.13	0.35	1.05	20
SYN 2	47.56	0.37	0.77	20
SYN 3	62.61	0.55	0.87	20
Vigil Lipid 1	23.11	0.38	1.64	20
Vigil Lipid 2	58.94	0.78	1.33	20
Vigil Lipid 4	99.79	1.39	1.39	20

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.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

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

HAY 1 4 2010

Re: K100010

Trade/Device Name: SYNCHRON® Systems HDL Cholesterol (HDLX) Reagent Regulation Number: 21 CFR 8862.1475 Regulation Name: Lipoprotein Test System Regulatory Class: Class I; meets limitations of exemptions under 21 CFR § 862.9 (c)(2) Product Code: LBS Dated: May 10, 2010 Received: May 11, 2010

Dear Yvette 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, 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); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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

Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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

Enclosure

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

Indications for Use

510(k) Number (if known): K100010

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

Indications for Use:

Prescription Use X (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 Device Evaluation and Safety (OIVD)

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

KI000/D_ 510(k) =

Page 1 of 1

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.