(47 days)
Not Found
No
The summary describes a chemical reagent and its use with a clinical chemistry analyzer, with no mention of AI or ML. The performance studies focus on standard analytical chemistry metrics like method comparison and imprecision.
No.
This device is a diagnostic device intended for determining cholesterol levels, not for treating a medical condition.
Yes
The device is intended for the "quantitative determination of human cholesterol in serum or plasma," which is a measurement used for diagnostic purposes.
No
The device is a reagent, which is a chemical substance used in a chemical reaction, and is intended for use with clinical chemistry analyzers. This indicates it is a physical component, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of human cholesterol in serum or plasma." This indicates the device is used to analyze biological samples in vitro (outside the body) to provide diagnostic information.
- Device Description: The description mentions it's a "Reagent" used in conjunction with a "Calibrator" on "clinical chemistry analyzers." Reagents and calibrators are common components of IVD test systems.
- Performance Studies: The document includes performance studies like "method comparison studies and imprecision experiments," which are standard evaluations for IVD devices to demonstrate their accuracy and reliability.
- Predicate Devices: The listing of predicate devices with K numbers (FDA premarket notification numbers) further confirms that this device is being compared to other legally marketed IVD devices.
The core function of analyzing a biological sample (serum or plasma) to measure a specific analyte (cholesterol) for diagnostic purposes clearly falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SYNCHRON Systems Cholesterol (CHOL) Reagent, when used in conjunction with SYNCHRON Systems Multi Calibrator, is intended for the quantitative determination of human cholesterol in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, Inc., such as the SYNCHRON LX™20 Clinical System.
Product codes (comma separated list FDA assigned to the subject device)
CHH
Device Description
The SYNCHRON Systems Cholesterol (CHOL) Reagent in conjunction with SYNCHRON Systems Multi Calibrator, is intended for use on Beckman's SYNCHRON Systems Clinical Systems.
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
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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 studies and imprecision experiments that relate results obtained from SYNCHRON Systems Cholesterol Reagent.
Method Comparison Study Results for SYNCHRON Systems Cholesterol (CHOL) Reagent:
- Reagent: SYNCHRON Systems Cholesterol (CHOL) Reagent; Slope: 0.983; Intercept: 2.41 mg/dL; r: 0.9996; n: 79; Predicate Method: SYNCHRON Systems Cholesterol (CHOL) Reagent
- Reagent: SYNCHRON Systems Cholesterol (CHOL) Reagent; Slope: 1.002; Intercept: -2.07 mg/dL; r: 0.9961; n: 39; Predicate Method: Abell-Kendall Reference Method
Estimated Within-Run Imprecision Cholesterol Reagent:
- Within-Run Imprecision Default Range:
- Level 1: Mean: 98.7 mg/dL; S.D.: 1.08 mg/dL; %C.V.: 1.09; N: 80
- Level 2: Mean: 155.4 mg/dL; S.D.: 1.65 mg/dL; %C.V.: 1.06; N: 80
- Level 3: Mean: 213.2 mg/dL; S.D.: 20.8 mg/dL; %C.V.: 0.98; N: 80
- Within-Run Imprecision Extended Range:
- Level 1: Mean: 716.2 mg/dL; S.D.: 12.53 mg/dL; %C.V.: 2.28; N: 20
- Level 2: Mean: 876.25 mg/dL; S.D.: 19.94 mg/dL; %C.V.: 1.74; N: 20
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.
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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
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(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
Kanisos
June 11, 1997
Summary of Safety & Effectiveness SYNCHRON® Systems Cholesterol (CHOL) Reagent
1.0 Submitted By:
Maria Zeballos Scientist II, Chemistry Development Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-150 Brea, California 92822-8000 Telephone: (714) 961-4435 FAX: (714) 961-3740
2.0 Date Submitted:
18 April 1997
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON® Systems Cholesterol (CHOL) Reagent
3.2 Classification Names
Cholesterol (Total) Test system (21 CFR 862.1175)
1
Predicate Device(s): 4.0
| SYNCHRON
Reagent | Predicate | Predicate
Company | Docket
Number |
|---------------------------------------------------|------------------------------------------------------|------------------------------|--------------------|
| SYNCHRON Systems
Cholesterol (CHOL)
Reagent | SYNCHRON CX
Systems Cholesterol
(CHOL) Reagent | Beckman
Instruments, Inc. | K934046 |
| SYNCHRON
CX4/CX5 Systems | ASTRA &
SYNCHRON CX3 | Beckman
Instruments, Inc | K881498
K881495 |
| SYNCHRON CX5CE
System | SYNCHRON
CX4/CX5 Systems | Beckman
Instruments, Inc | K926060 |
| SYNCHRON
CX4CE/CX7 System | SYNCHRON
CX4/CX5 Systems | Beckman
Instruments, Inc | K904220
K904219 |
| SYNCHRON Systems
CX4/CX5 Systems | SYNCHRON Systems
CX4/CX5 Systems | Beckman
Instruments, Inc | K950958 |
| SYNCHRON LX 20
System | SYNCHRON CX7
DELTA System | Beckman
Instruments, Inc. | K965240 |
5.0 Description:
The SYNCHRON Systems Cholesterol (CHOL) Reagent in conjunction with SYNCHRON Systems Multi Calibrator, is intended for use on Beckman's SYNCHRON Systems Clinical Systems.
6.0 Intended Use:
The SYNCHRON Systems Cholesterol (CHOL) Reagent, when used in conjunction with SYNCHRON Systems Multi Calibrator, is intended for the quantitative determination of human cholesterol in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON LX™20 Clinical System.
2
7.0 Comparison to Predicate(s):
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
| Reagent | Aspect/
Characteristic | Comments |
|---------------------------------------------------------|---------------------------|---------------------------------------------------------------------------|
| SIMILARITIES | | |
| SYNCHRON
Systems
Cholesterol
(CHOL)
Reagent | Intended use | Same; determination of
cholesterol concentration in
serum or plasma |
| | Chemical reaction | Same; enzymatic, Cholesterol
Oxidase reaction |
| | Measurement
method | Same; endpoint measurement at
520 nm |
| | Packaging | Same; a two cartridge reagent kit |
| | Reaction time | Same; 32 seconds |
| | Calibration | Same; single level serum base
calibrator |
| Reagent | Aspect/
Characteristic | Comments |
|---------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DIFFERENCES | | |
| SYNCHRON
Systems
Cholesterol
(CHOL)
Reagent | Range expansion | The SYNCHRON CX Systems
measures cholesterol
concentrations at the initial range
of 5 -750 mg/dL; while the
SYNCHRON LX Systems
measures cholesterol
concentrations at the initial range
of 5-750 mg/dL and expanded
range of 600 - 1000 mg/dL |
10_sse, 04/97
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 studies and imprecision experiments that relate results obtained from SYNCHRON Systems Cholesterol Reagent.
| Reagent
(Analyte) | Slope | Intercept
(mg/dL) | r | n | Predicate Method |
|---------------------------------------------------------|-------|----------------------|--------|----|---------------------------------------------------------|
| SYNCHRON
Systems
Cholesterol
(CHOL)
Reagent | 0.983 | 2.41 | 0.9996 | 79 | SYNCHRON
Systems
Cholesterol
(CHOL)
Reagent |
| SYNCHRON
Systems
Cholesterol
(CHOL)
Reagent | 1.002 | -2.07 | 0.9961 | 39 | Abell-Kendall
Reference
Method |
Method Comparison Study Results SYNCHRON Systems Cholesterol (CHOL) Reagent
Estimated Within-Run Imprecision Cholesterol Reagent
| Sample | Mean
(mg/dL) | S.D.
(mg/dL) | %C.V. | N | |
|---------------------------------------|-----------------|-----------------|-------|----|--|
| Within-Run Imprecision Default Range | | | | | |
| Level 1 | 98.7 | 1.08 | 1.09 | 80 | |
| Level 2 | 155.4 | 1.65 | 1.06 | 80 | |
| Level 3 | 213.2 | 20.8 | 0.98 | 80 | |
| Within-Run Imprecision Extended Range | | | | | |
| Level 1 | 716.2 | 12.53 | 2.28 | 20 | |
| Level 2 | 876.25 | 19.94 | 1.74 | 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.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 1 1997
Sheri Hall Manager, Premarket Regulatory Beckman_Instruments _ Inc ... . 200 S. Kraemer Boulevard, M/S W-337 P.O. Box 8000 Brea, California 92822-8000 48 Re : K971505 SYNCHRON® Systems Cholesterol (CHOL) Reagent Regulatory Class: I Product Code: CHH Dated: April 18, 1997 Received: April 25, 1997
Dear Ms. Hall:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 reqistration, 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 (Premarket Approval), 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 895. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
5
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 predicate 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 requlation (21 CFR Part 801 and 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
sincerely yours,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
6
of page -
510(k) Number (if known):
Device Name:
Indications for Use:
The SYNCHRON Systems Cholesterol (CHOL) Reagent, when used in conjunction with SYNCHRON Systems Multi Calibrator, is intended for the quantitative determination of human cholesterol in serum or plasma. This assay is designed for use with clinical chemistry analyzers from Beckman instruments, such as the SYNCHRON LX20 Clinical System.
21 CFR 862.1175 Cholesterol (total) test system
(a) Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorder involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
(b) Classification. Class II.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number
K947555
510(k) Number
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use Optional Format 1-2-96