(34 days)
Not Found
No
The summary describes a reagent and calibrator for a chemistry analyzer, with performance studies focused on standard analytical metrics like method comparison and imprecision. There is no mention of AI or ML.
No
This device is an in vitro diagnostic reagent and calibrator used for the quantitative determination of HDL Cholesterol, not a therapeutic device.
Yes
The device is intended for the quantitative determination of HDL Cholesterol in human serum or plasma, which is a measurement used by clinicians to diagnose or monitor medical conditions.
No
The device description clearly states it is a reagent and calibrator, which are physical components used in conjunction with laboratory systems (SYNCHRON LX® and CX®). It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the quantitative determination of HDL Cholesterol in human serum or plasma. This is a diagnostic measurement performed on a biological sample outside of the body.
- Device Description: The description details reagents and calibrators used in a laboratory setting for testing.
- Performance Studies: The performance studies describe method comparison and imprecision experiments, which are typical evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Devices: The predicate devices listed are also IVD reagents and calibrators for lipid testing.
All of these factors indicate that the device is intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
Reagent:
HDL reagent, when used in conjunction with SYNCHRON LX® System(s) and SYNCHRON® Systems Lipid Plus Calibrator, is intended for the quantitative determination of HDL Cholesterol (HDL) in the high density lipoprotein (HDL) fraction of human serum or plasma.
HDL reagent, when used in conjunction with SYNCHRON CX® CE/DELTA/PRO System(s) and SYNCHRON® Systems Lipid Plus Calibrator, is intended for the quantitative determination of HDL Cholesterol (HDL) in the high density lipoprotein (HDL) fraction of human serum or plasma.
Calibrator:
The SYNCHRON® Systems Lipid Plus Calibrator 1& 2, in conjunction with specified assays on the SYNCHRON® Systems, are intended to provide points of reference in the measurement of selected human lipids and proteins.
Product codes (comma separated list FDA assigned to the subject device)
JIT, LBS
Device Description
Reagent
The SYNCHRON LX® and CX® CE/DELTA/PRO System(s) HDL reagent is designed for optimal performance on the SYNCHRON LX® and CX® CE/DELTA/PRO System(s). The reagent kit contains two 200-test cartridges that are packaged separately from the associated calibrators.
Calibrator
The SYNCHRON® Systems Lipid Plus Calibrator set is a two level readyto-use human serum-based liquid calibrator set manufactured by Beckman Coulter, Inc. Each kit contains 1 X 3 mL bottles of each level of calibrator (identified as Level 1 and Level 2).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
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, stability, linearity, and imprecision experiments.
Method Comparison Study Results:
Instrument: SYNCHRON CX, Slope: 0.992, Intercept: -2.8, r: 0.994, n: 79, Comparison Method: SYNCHRON HDLD
Instrument: SYNCHRON LX, Slope: 1.000, Intercept: -2.8, r: 0.993, n: 79, Comparison Method: SYNCHRON HDLD
SYNCHRON CX System HDL Reagent Imprecision Results:
Sample: Within-Run Imprecision, Level 1, Mean (mg/dL): 28.0, S.D. (mg/dL): 0.5, %C.V.: 1.6, N: 80
Sample: Within-Run Imprecision, Level 2, Mean (mg/dL): 57.6, S.D. (mg/dL): 0.9, %C.V.: 1.5, N: 80
Sample: Within-Run Imprecision, Level 3, Mean (mg/dL): 76.3, S.D. (mg/dL): 2.1, %C.V.: 2.8, N: 80
Sample: Total Imprecision, Level 1, Mean (mg/dL): 28.0, S.D. (mg/dL): 1.4, %C.V.: 5.1, N: 80
Sample: Total Imprecision, Level 2, Mean (mg/dL): 57.6, S.D. (mg/dL): 1.4, %C.V.: 2.4, N: 80
Sample: Total Imprecision, Level 3, Mean (mg/dL): 76.3, S.D. (mg/dL): 2.6, %C.V.: 3.4, N: 80
SYNCHRON LX System HDL Reagent Imprecision Results:
Sample: Within-Run Imprecision, Level 1, Mean (mg/dL): 27.6, S.D. (mg/dL): 0.3, %C.V.: 1.2, N: 80
Sample: Within-Run Imprecision, Level 2, Mean (mg/dL): 56.0, S.D. (mg/dL): 0.8, %C.V.: 1.5, N: 80
Sample: Within-Run Imprecision, Level 3, Mean (mg/dL): 72.7, S.D. (mg/dL): 1.7, %C.V.: 2.3, N: 80
Sample: Total Imprecision, Level 1, Mean (mg/dL): 27.6, S.D. (mg/dL): 1.7, %C.V.: 6.1, N: 80
Sample: Total Imprecision, Level 2, Mean (mg/dL): 56.0, S.D. (mg/dL): 1.6, %C.V.: 2.9, N: 80
Sample: Total Imprecision, Level 3, Mean (mg/dL): 72.7, S.D. (mg/dL): 1.9, %C.V.: 2.6, N: 80
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
Not Found
§ 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.
0
SEP 16 2004
K 042195
510(k) Summary SYNCHRON® Systems HDL Cholesterol Reagent and Lipid Plus Calibrators 1 & 2
1.0 Submitted By:
Kim Walker Regulatory Affairs Manager Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 961-4912 FAX: (714) 961-4123
2.0 Date Submitted:
August 11, 2004
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON® Systems HDL Cholesterol (HDL) Reagent SYNCHRON® Systems Lipid Plus Calibrators 1 & 2
3.2 Classification Name
Lipoprotein test system (21 CFR § 862.1475) Calibrator, Primary (21 CFR § 862.1150)
4.0 Predicate Devices:
| Candidate(s) | Predicate | Manufacturer | Docket
Number |
|------------------------------------------------------|------------------------------------------|--------------------------|------------------|
| SYNCHRON
Systems
HDL Reagent | SYNCHRON
Systems
HDLD Reagent | Beckman
Coulter, Inc. | K040767 |
| SYNCHRON®
Systems Lipid Plus
Calibrators 1 & 2 | SYNCHRON®
Systems Lipid
Calibrator | Beckman
Coulter, Inc. | K983640 |
Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON HDL Cholesterol (HDL) Reagent SYN_HDL510K_Section1.doc, August 2004
1
Description: 5.0
Reagent
The SYNCHRON LX® and CX® CE/DELTA/PRO System(s) HDL reagent is designed for optimal performance on the SYNCHRON LX® and CX® CE/DELTA/PRO System(s). The reagent kit contains two 200-test cartridges that are packaged separately from the associated calibrators.
Calibrator
The SYNCHRON® Systems Lipid Plus Calibrator set is a two level readyto-use human serum-based liquid calibrator set manufactured by Beckman Coulter, Inc. Each kit contains 1 X 3 mL bottles of each level of calibrator (identified as Level 1 and Level 2).
6.0 Intended Use:
Reagent
HDL reagent, when used in conjunction with SYNCHRON LX® System(s) and SYNCHRON® Systems Lipid Plus Calibrator, is intended for the quantitative determination of HDL Cholesterol (HDL) in the high density lipoprotein (HDL) fraction of human serum or plasma.
HDL reagent, when used in conjunction with SYNCHRON CX® CE/DELTA/PRO System(s) and SYNCHRON® Systems Lipid Plus Calibrator, is intended for the quantitative determination of HDL Cholesterol (HDL) in the high density lipoprotein (HDL) fraction of human serum or plasma.
Calibrator
The SYNCHRON Systems Lipid Plus Calibrators 1& 2, in conjunction with specified assays on the SYNCHRON® Systems, are intended to provide points of reference in the measurement of selected human lipids and proteins.
7.0 Comparison to Predicate(s):
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
2
Similarities to the Predicate
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| HDL | ||
| Reagent | Intended Use | Same as Beckman |
| SYNCHRON HDLD | ||
| Reagent | ||
| Liquid Stable Reagent | ||
| Analytical Range | ||
| Sample Type | ||
| Reference Intervals | ||
| Shelf Life Stability | ||
| Lipid Plus | ||
| Calibrator | Liquid Stable Calibrator | Same as Beckman |
| SYNCHRON Lipid | ||
| Calibrator | ||
| Value Assignment Methodology | ||
| Storage Temperature (-15°C to -20°C) | ||
| Levels of Analyte (2 levels) |
Differences From The Predicate
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| HDL | ||
| Reagent | Sample Size | HDLD is 3 $\mu$ l, HDL is 4 $\mu$ l |
| Methodology | HDLD uses solubilization polyanion; HDL uses a | |
| cholesterol oxidase acceleration and dissolving | ||
| of HDL by use of a specific detergent. | ||
| Reactive | ||
| Ingredients | HDL added Ascorbic oxidase, removed the | |
| Polyanion and increased the detergent | ||
| concentration. | ||
| Interferences | HDLD Ascorbic acid 50 mg/dL; HDL 100 mg/dL | |
| HDLD IgG 3000 mg/dL; HDL 5000 mg/dL | ||
| Lipid Plus | ||
| Calibrator | Intended Use | The SYNCHRON® Systems Lipid Calibrator is |
| intended for use with the SYNCHRON Systems | ||
| for the calibration of direct HDL Cholesterol | ||
| reagent. |
SYNCHRON Systems Lipid Plus Calibrators 1 &
2 are stabilized liquid calibrators designed for
use with SYNCHRON® Systems for the
calibration of Lipids and Proteins. |
| | Shelf Life Stability | Lipid Calibrator is stable up to 18 months; Lipid
Plus Calibrator is stable up to 24 months |
| | Source Material | Lipid Calibrator contains defibrinated human
plasma spiked with human lipids; Lipid Plus
Calibrator is human serum based and contains
endogenous levels of HDL |
3
Summary of Performance Data: 8.0
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.
| Instrument | Slope | Intercept | r | n | Comparison Method |
|---|---|---|---|---|---|
| SYNCHRON CX | 0.992 | -2.8 | 0.994 | 79 | SYNCHRON HDLD |
| SYNCHRON LX | 1.000 | -2.8 | 0.993 | 79 | SYNCHRON HDLD |
Method Comparison Study Results
SYNCHRON CX System HDL Reagent Imprecision Results
| Sample | Mean
(mg/dL) | S.D.
(mg/dL) | %C.V. | N |
|------------------------|-----------------|-----------------|-------|----|
| Within-Run Imprecision | | | | |
| Level 1 | 28.0 | 0.5 | 1.6 | 80 |
| Level 2 | 57.6 | 0.9 | 1.5 | 80 |
| Level 3 | 76.3 | 2.1 | 2.8 | 80 |
| Total Imprecision | | | | |
| Level 1 | 28.0 | 1.4 | 5.1 | 80 |
| Level 2 | 57.6 | 1.4 | 2.4 | 80 |
| Level 3 | 76.3 | 2.6 | 3.4 | 80 |
SYNCHRON LX System HDL Reagent Imprecision Results
| Sample | Mean
(mg/dL) | S.D.
(mg/dL) | %C.V. | N |
|------------------------|-----------------|-----------------|-------|----|
| Within-Run Imprecision | | | | |
| Level 1 | 27.6 | 0.3 | 1.2 | 80 |
| Level 2 | 56.0 | 0.8 | 1.5 | 80 |
| Level 3 | 72.7 | 1.7 | 2.3 | 80 |
| Total Imprecision | | | | |
| Level 1 | 27.6 | 1.7 | 6.1 | 80 |
| Level 2 | 56.0 | 1.6 | 2.9 | 80 |
| Level 3 | 72.7 | 1.9 | 2.6 | 80 |
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.
Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON HDL Cholesterol (HDL) Reagent SYN_HDL510K_Section1.doc, August 2004
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (U.S.A.). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design with three parallel lines that curve and overlap, resembling a stylized representation of a human form or a medical symbol.
Public Health Service
SEP 1 6 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kim Walker Regulatory Affairs Manager Beckman Coulter, Inc. 200 S. Kraemer Boulevard P.O. Box 8000 Brea, CA 92822-8000
Re: K042195
Trade/Device Name: SYNCHRON® Systems HDL Cholesterol (HDL) Reagent SYNCHRON® Systems Lipid Plus Calibrators 1&2 Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT, LBS Dated: August 11, 2004 Received: August 13, 2004
Dear Ms. Walker:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation 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 Division of Small Manufacturers, 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
6
Indications for Use
510(k) Number (if known): K042195
Device Name:
SYNCHRON® Systems HDL Cholesterol (HDL) Reagent SYNCHRON® Systems Lipid Plus Calibrators 1 & 2
Indications for Use:
Reagent:
HDL reagent, when used in conjunction with SYNCHRON LX® System(s) and SYNCHRON® Systems Lipid Plus Calibrator, is intended for the quantitative determination of HDL Cholesterol (HDL) in the high density lipoprotein (HDL) fraction of human serum or plasma.
HDL reagent, when used in conjunction with SYNCHRON CX® CE/DELTA/PRO System(s) and SYNCHRON® Systems Lipid Plus Calibrator, is intended for the quantitative determination of HDL Cholesterol (HDL) in the high density lipoprotein (HDL) fraction of human serum or plasma.
Calibrator:
The SYNCHRON® Systems Lipid Plus Calibrator 1& 2, in conjunction with specified assays on the SYNCHRON® Systems, are intended to provide points of reference in the measurement of selected human lipids and proteins.
ﺴﺎ Over-The-Counter Use Prescription Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Qffice of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) K042195
Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON HDL Cholesterol (HDL) Reagent SYN HDL510K Section1.doc, August 2004