(46 days)
Not Found
No
The summary describes a chemical reagent and associated calibrator for a standard clinical chemistry analyzer, with performance demonstrated through method comparison and imprecision studies. There is no mention of AI, ML, or any computational analysis beyond standard quantitative determination.
No
The device is intended for the quantitative determination of LDL cholesterol, which is a diagnostic function, not a therapeutic one. It measures a substance in the body rather than treating a condition.
Yes
The device is intended for the "quantitative determination of low-density lipoprotein cholesterol (LDL cholesterol) in human serum or plasma," which is a diagnostic measurement used to assess a patient's health status and risk for cardiovascular disease.
No
The device description clearly states it is a "Reagent" and a "reagent kit," which are physical components used in a laboratory setting for chemical analysis. It is intended for use on specific SYNCHRON Clinical Systems, which are hardware analyzers. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the reagent is "intended for the quantitative determination of low-density lipoprotein cholesterol (LDL cholesterol) in human serum or plasma". This indicates that the device is used to test samples taken from the human body (in vitro) to provide diagnostic information.
- Device Description: The description further clarifies that the assay is for the "quantitative determination of low-density lipoprotein cholesterol concentration in human serum or plasma". This reinforces the in vitro nature of the testing.
- Performance Studies: The performance studies describe analyzing "Serum patient specimens", which are samples taken from patients.
- Predicate Device: The mention of a "Predicate Device" (K971573; N-Geneous LDL Cholesterol Reagent) is common for IVD submissions to regulatory bodies like the FDA, as it demonstrates substantial equivalence to a previously cleared IVD.
All these points strongly indicate that the device is designed and used for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
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.
LDL cholesterol is directly related to the risk of developing coronary heart disease. Elevated LDL cholesterol is the primary target of cholesterol-lowering therapy.
Product codes (comma separated list FDA assigned to the subject device)
LBR, JIS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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*:
SYNCHRON LX vs. N-Geneous. 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.
Estimated SYNCHRON LX LDLD Assay Imprecision:
Sample within-run imprecision at 80 samples for levels 1, 2, and 3: 1.1%, 1.4%, 1.2% (CV) for mean (mg/dL) of 49.9, 211.9, 410.4 respectively.
Total imprecision at 80 samples for levels 1, 2, and 3: 2.9%, 1.8%, 1.6% (CV) for mean (mg/dL) of 49.9, 211.9, 410.4 respectively.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Reportable Range: SYNCHRON: 10 to 550 mg/dL; Genzyme: 6.6 to 992 mg/dL
Limit of Detection: SYNCHRON: 8 mg/dL; Genzyme: 0.278 mg/dL
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a black oval shape with two white curved lines inside, resembling a stylized eye or a wave pattern. To the right of the oval is the company name, "BECKMAN COULTER," with "BECKMAN" on the top line and "COULTER" on the bottom line, both in bold, sans-serif font.
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 | Docket
Number |
|---------------------------------------------------------------|--------------------------------------|-------------------------|------------------|
| SYNCHRON® Systems
Direct LDL Cholesterol
(LDLD) Reagent | N-Geneous LDL
Cholesterol Reagent | Genzyme
Corporation* | 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
1
7.0 Comparison to Predicate(s):
| Assay | Aspect/Characteristic | Comments |
|---|---|---|
| SIMILARITIES | ||
| SYNCHRON® Systems | ||
| LDLD Reagent and | ||
| Calibrator | 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/dL | |
| Genzyme*: 6.6 to 992 mg/dL | ||
| Limit of Detection | SYNCHRON: 8 mg/dL | |
| Genzyme: 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 |
|--------------|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------------------------------|
| SYNCHRO
2 | | 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 Use |
| Optional Format 1-2-96 |