(34 days)
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.
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).
This document describes the SYNCHRON® Systems HDL Cholesterol (HDL) Reagent and SYNCHRON® Systems Lipid Plus Calibrators 1 & 2.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as pass/fail thresholds in the typical sense for a diagnostic device algorithm. Instead, it presents performance data to demonstrate substantial equivalence to a predicate device. The performance is assessed through method comparison and imprecision studies.
Since the device is a reagent and calibrator for laboratory analysis, the "acceptance criteria" are implicitly met when the performance data shows comparable results to the predicate device and within expected analytical ranges for such tests. For this type of device, the correlation (r-value) in method comparison and precision (CV%) are key indicators of performance.
Implicit Acceptance Criteria and Reported Performance for SYNCHRON® Systems HDL Reagent:
| Performance Metric | Acceptance Criteria (Implicit, based on typical clinical chemistry standards for substantial equivalence) | Reported Device Performance (SYNCHRON HDL) |
|---|---|---|
| Method Comparison (vs. Predicate SYNCHRON HDLD) | Slope close to 1.0, Intercept close to 0, and a high correlation coefficient (r > 0.95 or 0.975 typically) | SYNCHRON CX: Slope = 0.992, Intercept = -2.8, r = 0.994 (n=79) SYNCHRON LX: Slope = 1.000, Intercept = -2.8, r = 0.993 (n=79) |
| Within-Run Imprecision (%CV) | Usually < 5-10% depending on analyte and concentration | SYNCHRON CX: Level 1: 1.6%, Level 2: 1.5%, Level 3: 2.8% (all n=80) SYNCHRON LX: Level 1: 1.2%, Level 2: 1.5%, Level 3: 2.3% (all n=80) |
| Total Imprecision (%CV) | Usually < 5-15% depending on analyte and concentration | SYNCHRON CX: Level 1: 5.1%, Level 2: 2.4%, Level 3: 3.4% (all n=80) SYNCHRON LX: Level 1: 6.1%, Level 2: 2.9%, Level 3: 2.6% (all n=80) |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (Method Comparison): n = 79 samples were used for the method comparison study conducted on both the SYNCHRON CX and SYNCHRON LX instruments.
- Test Set (Imprecision/Precision):
- For SYNCHRON CX: n = 80 for each of the three levels (Level 1, Level 2, Level 3) for both within-run and total imprecision.
- For SYNCHRON LX: n = 80 for each of the three levels (Level 1, Level 2, Level 3) for both within-run and total imprecision.
- Data Provenance: The document does not specify the country of origin of the data. It appears to be from internal studies conducted by Beckman Coulter, Inc., as part of their 510(k) submission. The data is retrospective in the sense that it was collected prior to submission for regulatory clearance, but it is generated specifically for this filing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This product is a chemical reagent and calibrator, not an AI or imaging device that requires interpretation by experts to establish ground truth.
- Ground Truth: For method comparison, the "ground truth" and reference method is the predicate device, SYNCHRON HDLD. Its measurements are used as the reference against which the new device's measurements are compared. The accuracy of the predicate device's measurements is assumed/established through its own validation and regulatory clearance.
- No Experts: Therefore, no human experts were involved in establishing "ground truth" for the test set in the way you might for an AI diagnostic device (e.g., radiologists reviewing images). The ground truth is analytical measurement against a validated reference method.
4. Adjudication Method for the Test Set:
Not applicable. As explained in point 3, this is a chemical assay, not an interpretive task requiring expert adjudication. The comparison is quantitative to a reference method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is a chemical reagent and calibrator, not an AI or imaging diagnostic device that would involve human readers. Therefore, an MRMC study and effect size of human improvement with AI assistance are not relevant to this type of product.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This device is a reagent and calibrator used on an automated instrument (SYNCHRON LX and CX systems). Its performance is inherently "standalone" in the sense that the instrument processes the sample and measures the HDL cholesterol concentration without human interpretation of the raw signal to determine the result. The human element is in operating the instrument, loading samples, and reviewing the final numerical result. The performance data presented (method comparison, imprecision) reflects the standalone analytical performance of the reagent/calibrator/instrument system.
7. Type of Ground Truth Used:
The ground truth used for the method comparison study is the analytical measurement obtained from the predicate device (SYNCHRON HDLD). This implicitly relies on the established accuracy and precision of the predicate device. For imprecision studies, the ground truth is the mean value of the repeated measurements for each sample level.
8. Sample Size for the Training Set:
This document describes a chemical reagent and calibrator, not a machine learning or AI model that requires a "training set" in the context of algorithm development. The development process for such a product involves formulation, optimization, and rigorous testing, but not "training data" in the AI sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" for this type of product. The "ground truth" for the development and validation of such a chemical assay involves established analytical chemistry principles, reference materials, accuracy assessments against recognized methods (e.g., CDC reference methods, if applicable), and internal quality control processes.
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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 | DocketNumber |
|---|---|---|---|
| SYNCHRONSystemsHDL Reagent | SYNCHRONSystemsHDLD Reagent | BeckmanCoulter, Inc. | K040767 |
| SYNCHRON®Systems Lipid PlusCalibrators 1 & 2 | SYNCHRON®Systems LipidCalibrator | BeckmanCoulter, Inc. | K983640 |
Beckman Coulter, Inc., Section 510(k) Notification SYNCHRON HDL Cholesterol (HDL) Reagent SYN_HDL510K_Section1.doc, August 2004
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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.
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Similarities to the Predicate
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| HDLReagent | Intended Use | Same as BeckmanSYNCHRON HDLDReagent |
| Liquid Stable Reagent | ||
| Analytical Range | ||
| Sample Type | ||
| Reference Intervals | ||
| Shelf Life Stability | ||
| Lipid PlusCalibrator | Liquid Stable Calibrator | Same as BeckmanSYNCHRON LipidCalibrator |
| Value Assignment Methodology | ||
| Storage Temperature (-15°C to -20°C) | ||
| Levels of Analyte (2 levels) |
Differences From The Predicate
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| HDLReagent | Sample Size | HDLD is 3 $\mu$ l, HDL is 4 $\mu$ l |
| Methodology | HDLD uses solubilization polyanion; HDL uses acholesterol oxidase acceleration and dissolvingof HDL by use of a specific detergent. | |
| ReactiveIngredients | HDL added Ascorbic oxidase, removed thePolyanion and increased the detergentconcentration. | |
| Interferences | HDLD Ascorbic acid 50 mg/dL; HDL 100 mg/dLHDLD IgG 3000 mg/dL; HDL 5000 mg/dL | |
| Lipid PlusCalibrator | Intended Use | The SYNCHRON® Systems Lipid Calibrator isintended for use with the SYNCHRON Systemsfor the calibration of direct HDL Cholesterolreagent.SYNCHRON Systems Lipid Plus Calibrators 1 &2 are stabilized liquid calibrators designed foruse with SYNCHRON® Systems for thecalibration of Lipids and Proteins. |
| Shelf Life Stability | Lipid Calibrator is stable up to 18 months; LipidPlus Calibrator is stable up to 24 months | |
| Source Material | Lipid Calibrator contains defibrinated humanplasma spiked with human lipids; Lipid PlusCalibrator is human serum based and containsendogenous levels of HDL |
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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
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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).
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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
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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
§ 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.