The SYNCHRON® Systems Direct LDL Cholesterol (LDLD) Reagent, when used in conjunction with the SYNCHRON® Systems LDLD Calibrator, is intended for the quantitative determination of low-density lipoprotein cholesterol (LDL cholesterol) in human serum or plasma on SYNCHRON Clinical Systems.

Device Description

The SYNCHRON System Direct LDL Cholesterol (LDLD) Reagent is designed for optimal performance on the SYNCHRON CX (CX4/4CE/4J/4PRO, CX5/5CE/5Δ/5PRO, CX7/7RTS/7/7/7PRO, CX9ALX/9PRO) and LX (LX20/PRO) Systems. The assay is intended for use in the quantitative determination of low-density lipoprotein cholesterol concentration in human serum or plasma. The reagent kit contains two 100-test cartridges and is packaged with the single-level calibrator.

AI/ML Overview

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Acceptance Criteria": null,
    "Reported Device Performance": {
      "Method Comparison Study Results (SYNCHRON LX Systems vs. Genzyme N-Geneous on Hitachi 911)": {
        "Range of LDL cholesterol analyzed": "52 to 192 mg/dL",
        "Equation": {
          "SYNCHRON = ": "1.200 * N-Geneous"
        }
      },
      "Estimated SYNCHRON LX LDLD Assay Imprecision": {
        "Within-Run Imprecision": {
          "Level 1 (Mean 49.9 mg/dL)": {
            "S.D. (mg/dL)": "2.2",
            "%C.V.": "nil"
          },
          "Level 2 (Mean 211.9 mg/dL)": {
            "S.D. (mg/dL)": "2.9",
            "%C.V.": "1.4"
          },
          "Level 3 (Mean 410.4 mg/dL)": {
            "S.D. (mg/dL)": "5.0",
            "%C.V.": "1.2"
          }
        },
        "Total Imprecision": {
          "Level 1 (Mean 49.9 mg/dL)": {
            "S.D. (mg/dL)": "1.4",
            "%C.V.": "2.9"
          },
          "Level 2 (Mean 211.9 mg/dL)": {
            "S.D. (mg/dL)": "3.8",
            "%C.V.": "1.8"
          },
          "Level 3 (Mean 410.4 mg/dL)": {
            "S.D. (mg/dL)": "6.7",
            "%C.V.": "1.6"
          }
        }
      }
    }
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": {
    "Sample Size (for Imprecision Study)": "80 samples per level (Levels 1, 2, and 3)",
    "Data Provenance": "Not specified (neither country of origin nor retrospective/prospective is mentioned in the provided text)."
  },
  "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)": "Not applicable. The study involves a chemical assay for LDL cholesterol measurement, not expert-based interpretation.",
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. The study involves a chemical assay, and adjudication methods are typically used for qualitative or imaging-based assessments.",
  "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. This is a study of a diagnostic reagent, not an AI-assisted interpretation by human readers.",
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Yes, this study represents a standalone performance evaluation of the SYNCHRON® Systems Direct LDL Cholesterol Reagent.",
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The ground truth for the method comparison was implicitly the results obtained from the Genzyme N-Geneous LDL Cholesterol Reagent on the Hitachi 911 clinical analyzer, which is itself a predicate device for quantitative determination of LDL cholesterol. For imprecision, the ground truth is the statistical variation around the measured mean values.",
  "8. The sample size for the training set": "Not applicable. This is a reagent assay, not a machine learning model, so there isn't a 'training set' in the conventional sense. The development of the reagent would involve its own pre-clinical testing and optimization.",
  "9. How the ground truth for the training set was established": "Not applicable. See point 8."
}

Summary

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510(k) Summary SYNCHRON® Systems Direct LDL Cholesterol Reagent

Submitted By: 1.0

JAN 2 8 2002

Mary Beth Tang Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 961-3777 Fax: (714) 961-4123

Date Submitted: 2.0

December 12, 2001

3.0 Device Name(s):

3.1 Proprietary Names

SYNCHRON® Systems Direct LDL Cholesterol Reagent

3.2 Classification Name

Lipoprotein test system (21 CFR § 862.1475) Primary calibrator (21 CFR § 862.1150)

4.0 Predicate Device(s):

Beckman Coulter	Predicate	Manufacturer	DocketNumber
SYNCHRON® SystemsDirect LDL Cholesterol(LDLD) Reagent	N-Geneous LDLCholesterol Reagent	GenzymeCorporation*	K971573

*Genzyme, Corp., Cambridge, MA

5.0 Description:

The SYNCHRON System Direct LDL Cholesterol (LDLD) Reagent is designed for optimal performance on the SYNCHRON CX (CX4/4CE/4J/4PRO, CX5/5CE/5Δ/5PRO, CX7/7RTS/7/7/7PRO, CX9ALX/9PRO) and LX (LX20/PRO) Systems. The assay is intended for use in the quantitative determination of low-density lipoprotein cholesterol The reagent kit contains two 100-test concentration in human serum or plasma. cartridges and is packaged with the single-level calibrator.

6.0 Intended Use:

LDL Cholesterol (LDLD) Reagent, when used in conjunction with the SYNCHRON® Systems LDLD Calibrator, is intended for the quantitative determination of low-density lipoprotein cholesterol (LDL cholesterol) in human serum or plasma on SYNCHRON Clinical Systems.

Mailing Address: 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000

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7.0 Comparison to Predicate(s):

Assay	Aspect/Characteristic	Comments
SIMILARITIES
SYNCHRON® SystemsLDLD Reagent andCalibrator	Intended use	Same as predicate
	Methodology
	Chemical Reaction
	Sample Type
	Sample Size
	Storage conditions (+2°C to +8°C)
DIFFERENCES
	Reportable Range	SYNCHRON: 10 to 550 mg/dLGenzyme*: 6.6 to 992 mg/dL
	Limit of Detection	SYNCHRON: 8 mg/dLGenzyme: 0.278 mg/dL

*Hitachi 911 analyzer application

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 and imprecision experiments that relate results obtained from the SYNCHRON LDLD Reagent to the Genzyme N-Geneous LDL Cholesterol Reagent on the Hitachi 911 clinical analyzer.

Method Comparison Study Results*

	----------			Carle Camera Charles of Cara Ch
SYNCHRO2		1200		vme N-Geneous
15555		------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

*Serum patient specimens were analyzed in the range of 52 to 192 mg/dL LDL cholesterol. Data shown was collected using SYNCHRON LX Systems. Equivalency between SYNCHRON CX has been established by correlation analysis to SYNCHRON LX Systems. **Hitachi 911 Analyzer application

S.D. (mg/dL) = = = = = = %C.V. = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Mean (mg/dL) Sample Within-Run Imprecision 2.2 80 Level 1 49.9 1.1 Level 2 211.9 2.9 1.4 80 1.2 Level 3 410.4 5.0 80 Total Imprecision Level 1 49.9 1.4 2.9 80 Level 2 211.9 3.8 1.8 80 Level 3 410.4 6.7 1.6 80

Estimated SYNCHRON LX LDLD Assay Imprecision

The Summary of Safety and Effectiveness information for the SYNCHRON Systems LDLD Reagent is 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized image of three human profiles connected to a single body, which is a common symbol used by the department.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 8 2002

Ms. Mary Beth Tang Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. M/S W-104 Box 8000 Brea, CA 92822-8000

Re: K014103

Trade/Device Name: SYNCHRON® Systems Direct LDL Cholesterol Reagent Regulation Number: 21 CFR 862.1475; 21 CFR 862.1150 Regulation Name: Lipoprotein test system; Calibrator Regulatory Class: Class I; Class II Product Code: LBR; JIS Dated: December 12, 2001 Received: December 13, 2001

Dear Ms. Tang:

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 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 Part 801); 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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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate device results in a classification for your device and thus, 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 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, 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 premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Masufacturers 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,

Steven Putman

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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page 1 of 1

510(k) Number (if known): K014103

SYNCHRON® Systems Direct LDL Cholesterol Reagent Device Name:

Indications for Use:

The SYNCHRON® Systems Direct LDL Cholesterol (LDLD) Reagent, when The STNCHRON® OyStellis Direct No Driver Systems LDLD Calibrator, is intended used in Conjunetion with OTNor of low density lipoprotein cholesterol in for the qualitiative downlineason Coulter's SYNCHRON Systems by colorimetry.

LDL cholesterol is directly related to the risk of developing coronary heart Eise cholesterer is allow cholesterol ratio is directly related to the risk of disease. >> 100. 115 artery disease. Elevated LDL cholesterol is the primary target of cholesterol-lowering therapy.1

"Executive Summary of the Third Report of the National Cholesterol Education 1. Excedite "Guinmary" of the "halle" halled on and Treatment of High Blood : Togram (11) Adult Treatment Panel III)", JAMA, 285:2486 (2001).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan S. Altaie
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K014103
Prescription Use (per 21 CFR 801.109)	OR	Over-the-Counter UseOptional Format 1-2-96

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.