(70 days)
The SYNCHRON Systems Uric Acid (URIC) Reagent, in conjunction with SYNCHRON MULTI™ Callbrator, is intended for use in the quantitative determination of uric acid in serum, plasma, and urine samples. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems.
The SYNCHRON Systems Uric Acid (URIC) reagent is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LXTM Clinical Systems When used in conjunction with SYNCHRON MULTI™ Calibrator, it is intended for use in the quantitative determination of uric acid concentration in serum, plasma, and unne samples. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis. starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
Here's a summary of the acceptance criteria and study details for the SYNCHRON® Systems Uric Acid (URIC) Reagent, based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The device's performance was evaluated against a predicate device (Beckman SYNCHRON Uric Acid Reagent on the SYNCHRON CX System) to demonstrate substantial equivalence. The document doesn't explicitly state quantitative acceptance criteria thresholds but implies that performance values that are comparable to the predicate are acceptable.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (SYNCHRON LX System) |
|---|---|---|
| Method Comparison (Serum/Plasma) | Similar to predicate | Slope: 0.977, Intercept: -0.020 mg/dL, r: 0.9985 (n=79) |
| Method Comparison (Urine) | Similar to predicate | Slope: 0.995, Intercept: 0.116 mg/dL, r: 0.9990 (n=78) |
| Linearity (Serum - Default) | Linear across range | 0.5 - 12.0 mg/dL: linear |
| Linearity (Serum - ORDAC) | Linear across range | 9.0 - 21.0 mg/dL: linear (expanded range due to ORDAC) |
| Linearity (Urine) | Linear across range | 5.0 - 120 mg/dL: linear |
| Within-Run Imprecision (Level 1) | Low imprecision | Mean: 2.42 mg/dL, SD: 0.03 mg/dL, %C.V.: 1.1% (n=80) |
| Within-Run Imprecision (Level 2) | Low imprecision | Mean: 10.48 mg/dL, SD: 0.05 mg/dL, %C.V.: 0.5% (n=80) |
| Total Imprecision (Level 1) | Low imprecision | Mean: 2.42 mg/dL, SD: 0.05 mg/dL, %C.V.: 1.9% (n=80) |
| Total Imprecision (Level 2) | Low imprecision | Mean: 10.48 mg/dL, SD: 0.08 mg/dL, %C.V.: 0.8% (n=80) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Method Comparison (Serum/Plasma): 79 samples
- Method Comparison (Urine): 78 samples
- Imprecision (Within-Run & Total): 80 replicates per level (Level 1 and Level 2)
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a diagnostic reagent for quantitative measurement of uric acid, not an image analysis or interpretive device that requires expert review for ground truth. The "ground truth" in this context is the actual uric acid concentration as measured by the predicate device and the inherent chemical properties of the samples.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is a quantitative chemical assay, not an interpretive task requiring expert adjudication. The comparison is between the new device's readings and the predicate device's readings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No. An MRMC comparative effectiveness study is designed for evaluating the performance of diagnostic tools that involve human interpretation (e.g., radiologists reading images). This document describes a chemical reagent; therefore, such a study would not be relevant.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this entire study is a standalone performance evaluation of the SYNCHRON® Systems Uric Acid (URIC) Reagent on the SYNCHRON LX System. The performance metrics (method comparison, linearity, imprecision) directly reflect the device's analytical capabilities without human intervention in the measurement process itself, beyond operating the instrument.
7. The Type of Ground Truth Used
The ground truth for the performance studies was:
- Method Comparison: The measurements obtained from the Beckman SYNCHRON Uric Acid Reagent (URIC) on the SYNCHRON CX System (the predicate device) served as the reference for comparison.
- Linearity and Imprecision: The inherent chemical concentrations within the control samples and patient samples were the "ground truth." Linearity confirms the device's ability to accurately measure these concentrations across its claimed range, and imprecision evaluates the reproducibility of these measurements.
8. The Sample Size for the Training Set
Not applicable. This device is a chemical reagent and an associated analytical system. It is not an AI/ML device that requires a "training set" in the conventional sense. The performance characteristics described are based on analytical validation studies, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this chemical reagent and analytical system.
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Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON® Systems Uric Acid Reagent Summary of Safety & Effectiveness
K970919
MAY 21, 1997
Summary of Safety & Effectiveness SYNCHRON @ Systems Uric Acid (URIC) Reagent
Submitted By: 1.0
Sheri Hall Product Submissions Manager Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 993-8961 FAX: (714) 961-4457
Date Submitted: 2.0
3 March 1997
Device Name(s): 3.0
3.1 Proprietary Names
SYNCHRON® Systems Uric Acid (URIC) Reagent
Classification Name 3.2
Uric Acid test system. (21 CFR § 862.1775)
4.0 Predicate Device(s):
| Product | Predicate | PredicateCompany | DocketNumber |
|---|---|---|---|
| Beckman SYNCHRONSystems Uric Acid (URIC)Reagent as used on theSYNCHRON CX Systems | Beckman Dri-STAT® UricAcid Trinder Reagent | BeckmanInstruments, Inc | K881498 |
| SYNCHRON LX ClinicalSystem | SYNCHRON CX ClinicalSystems | BeckmanInstruments, Inc. | **K965240 |
** K965240 for the LX SYNCHRON System is currently under review.
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Beckman Instruments, Inc., Section 510(k) Notification SYNCHRON® Systems Uric Acid Reagent Summary of Safety & Effectiveness
5.0 Description:
The SYNCHRON Systems Uric Acid (URIC) reagent is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LXTM Clinical Systems When used in conjunction with SYNCHRON MULTI™ Calibrator, it is intended for use in the quantitative determination of uric acid concentration in serum, plasma, and unne samples. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis. starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
Intended Use: 6.0
The SYNCHRON Systems Uric Acid (URIC) reagent, in conjunction with SYNCHRON MULTI™ Calibrator, is intended for use in the quantitative determination of uric acid concentration in serum, plasma, and urine samples. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LXTM Clinical Systems.
7.0 Comparison to Predicate(s):
The following tables show similarities and differences between the predicates identified in Section 4.0 of this summary.
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| SYNCHRONSystems (URIC)Reagent | intended use | same:quantitative determination of uricacid in human serum, plasma, andurine |
| chemical reaction | same:a timed endpoint methodology | |
| reagent components andpackaging | same:same reagent formulation andpackaging materials | |
| measurement method | same:runs the reaction at 37°C and readsan endpoint at 520 nm | |
| measuring rangedefault range: serum/plasma | same:(0.5 - 12.0 mg/dL) | |
| urine range (with on-line or off-linedilution) | (5 - 120 mg/dL) | |
| calibration | same:single point update |
Similarities
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實問題 - 1
Differences
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| SYNCHRON Systems(URIC) Reagents | Measuring range expansion | The LX System may utilize ORDAC serumand plasma samples to expand themeasuring range to 9.0 mg/dL to 21.0mg/dL |
| Urine application | the LX System performs the 1:10 sampledilution onboard, where the CX Systemmust have the dilution prepared off-line |
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, linearity, and imprecision experiments that relate results obtained from the SYNCHRON Systems Uric Acid Reagent run on the SYNCHRON CX Systems to the SYNCHRON Systems Uric Acid Reagent run on the SYNCHRON Systems LX ..
Method Comparison Study Results
| Reagent(Analyte) | Slope | Intercept(mg/dL) | r | n | Predicate Method |
|---|---|---|---|---|---|
| Serum/PlasmaSYNCHRON UricAcid Reagent(URIC) on theSYNCHRON LXSystem | 0.977 | -0.020 | 0.9985 | 79 | Beckman SYNCHRONUric Acid Reagent(URIC) on theSYNCHRON CXSystem |
| UrineSYNCHRON UricAcid Reagent(URIC) on theSYNCHRON LXSystem | 0.995 | 0.116 | 0.9990 | 78 | Beckman SYNCHRONUric Acid Reagent(URIC) on theSYNCHRON CXSystem |
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Linearity Study Results
| Analyte | SampleType | Option | Measuring Range | Assessment |
|---|---|---|---|---|
| SYNCHRONSystems | serum | default | 0.5 - 12.0 mg/dL | linear |
| URIC | ORDAC | 5.0 - 120 mg/dL | linear | |
| Reagent | urine | default | 5.0 - 120 mg/dL | linear |
Estimated Imprecision
| SAMPLE | Mean(mg/dL) | SD(mg/dL) | %C.V. | N |
|---|---|---|---|---|
| Within-Run Imprecision | ||||
| Level 1 | 2.42 | 0.03 | 1.1% | 80 |
| Level 2 | 10.48 | 0.05 | 0.5% | 80 |
| Total Imprecision | ||||
| Level 1 | 2.42 | 0.05 | 1.9% | 80 |
| Level 2 | 10.48 | 0.08 | 0.8% | 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.
file: UA510KS.DOC
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling a bird or abstract human figure, composed of three curved lines.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 21 1997
Sheri Hall Manager, Premarket Regulatory Beckman Instruments, Inc. 200 S. Kraemer Boulevard, M/S W-337 P.O. Box 8000 92822-8000 Brea, California
K970919 Re : SYNCHRON® Systems Uric Acid (URIC) Reagent Requlatory Class: I Product Code: KNK Dated: March 5, 1997 Received: March 12, 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 maries 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 The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (curr ob), chib device major and 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 regulation entitled, "Misbranding by reference to ene regalation Chercroal (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 Litman
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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K9-709/9
page 1 of 1
510(k) Number (if known):
SYNCHRON® Systems Device Name: Uric Acid (URIC) Reagent
Indications for Use:
The SYNCHRON Systems Uric Acid (URIC) Reagent, in conjunction with SYNCHRON MULTI™ Callbrator, is intended for use in the quantitative determination of uric acid in serum, plasma, and urine samples. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems.
21 CFR § 862.1775 Uric acid Test System
(a) Identification. A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, starvation or other wasting conditions, and of patients receiving cytotoxic drugs. (b) Classification. Class I .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Honeymove for Almontgomery DVM | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices |
| >10(k) Number | K970919 |
|---|---|
| --------------- | --------- |
| Prescription Use(per 21 CFR 801.109) | OR | Over-the-Counter UseOptional Format 1-2-96 |
|---|---|---|
| ------------------------------------------ | ---- | ------------------------------------------------ |
§ 862.1775 Uric acid test system.
(a)
Identification. A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.(b)
Classification. Class I (general controls). The device, when it is solely intended for use as an acid reduction of ferric ion test, a phosphotungstate reduction test, a gasometric uricase test, an ultraviolet uricase test, or an oxygen rate uricase test, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.