(70 days)
No
The summary describes a chemical reagent and its use with standard clinical chemistry analyzers for quantitative determination of uric acid. There is no mention of AI, ML, or any computational methods beyond standard data processing for quantitative analysis.
No.
This device is an in-vitro diagnostic reagent used to quantitatively measure uric acid in samples, which aids in diagnosis and treatment, but does not itself provide therapy.
Yes
The Device Description explicitly states, "Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders." This indicates its role in the diagnostic process.
No
The device is a reagent, which is a chemical substance used in a test, and is intended for use with clinical chemistry analyzers (hardware). It 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 use in the quantitative determination of uric acid in serum, plasma, and urine samples." This is a classic description of an in vitro diagnostic test, as it involves analyzing biological samples outside of the body to obtain diagnostic information.
- Device Description: The "Device Description" further clarifies that the measurements obtained are "used in the diagnosis and treatment of numerous renal and metabolic disorders." This directly links the device's function to diagnostic purposes.
- Sample Types: The device is designed to analyze "serum, plasma, and urine samples," which are biological specimens commonly used in in vitro diagnostic testing.
- Clinical Chemistry Analyzers: The device is intended for use with "clinical chemistry analyzers," which are instruments specifically designed for performing in vitro diagnostic tests on biological fluids.
- Predicate Devices: The listed predicate devices (Beckman Dri-STAT® Uric Acid Trinder Reagent and SYNCHRON CX Clinical Systems) are also IVD devices, indicating that this device falls within the same regulatory category.
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SYNCHRON Systems Uric Acid (URIC) Reagent, in conjunction with SYNCHRON MULTI™ Calibrator, 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.
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.
Product codes
KNK
Device 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.
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
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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
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): Serum/Plasma SYNCHRON Uric Acid Reagent (URIC) on the SYNCHRON LX System
- Slope: 0.977
- Intercept (mg/dL): -0.020
- r: 0.9985
- n: 79
- Predicate Method: Beckman SYNCHRON Uric Acid Reagent (URIC) on the SYNCHRON CX System
- Reagent (Analyte): Urine SYNCHRON Uric Acid Reagent (URIC) on the SYNCHRON LX System
- Slope: 0.995
- Intercept (mg/dL): 0.116
- r: 0.9990
- n: 78
- Predicate Method: Beckman SYNCHRON Uric Acid Reagent (URIC) on the SYNCHRON CX System
Linearity Study Results:
- Analyte: SYNCHRON Systems URIC Reagent
- Sample Type: serum
- Option: default, Measuring Range: 0.5 - 12.0 mg/dL, Assessment: linear
- Option: ORDAC, Measuring Range: 5.0 - 120 mg/dL, Assessment: linear
- Sample Type: urine
- Option: default, Measuring Range: 5.0 - 120 mg/dL, Assessment: linear
- Sample Type: serum
Estimated Imprecision:
- Within-Run Imprecision:
- Sample: Level 1, Mean (mg/dL): 2.42, SD (mg/dL): 0.03, %C.V.: 1.1%, N: 80
- Sample: Level 2, Mean (mg/dL): 10.48, SD (mg/dL): 0.05, %C.V.: 0.5%, N: 80
- Total Imprecision:
- Sample: Level 1, Mean (mg/dL): 2.42, SD (mg/dL): 0.05, %C.V.: 1.9%, N: 80
- Sample: Level 2, Mean (mg/dL): 10.48, SD (mg/dL): 0.08, %C.V.: 0.8%, N: 80
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
**K965240
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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 | Predicate
Company | Docket
Number |
|-----------------------------------------------------------------------------------------------|------------------------------------------------|------------------------------|------------------|
| Beckman SYNCHRON
Systems Uric Acid (URIC)
Reagent as used on the
SYNCHRON CX Systems | Beckman Dri-STAT® Uric
Acid Trinder Reagent | Beckman
Instruments, Inc | K881498 |
| SYNCHRON LX Clinical
System | SYNCHRON CX Clinical
Systems | Beckman
Instruments, Inc. | **K965240 |
** K965240 for the LX SYNCHRON System is currently under review.
1
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 |
|---|---|---|
| SYNCHRON | ||
| Systems (URIC) | ||
| Reagent | intended use | same: |
| quantitative determination of uric | ||
| acid in human serum, plasma, and | ||
| urine | ||
| chemical reaction | same: | |
| a timed endpoint methodology | ||
| reagent components and | ||
| packaging | same: | |
| same reagent formulation and | ||
| packaging materials | ||
| measurement method | same: | |
| runs the reaction at 37°C and reads | ||
| an endpoint at 520 nm | ||
| measuring range | ||
| default range: serum/plasma | same: | |
| (0.5 - 12.0 mg/dL) | ||
| urine range (with on-line or off-line | ||
| dilution) | (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 serum |
| and plasma samples to expand the | ||
| measuring range to 9.0 mg/dL to 21.0 | ||
| mg/dL | ||
| Urine application | the LX System performs the 1:10 sample | |
| dilution onboard, where the CX System | ||
| must 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/Plasma
SYNCHRON Uric
Acid Reagent
(URIC) on the
SYNCHRON LX
System | 0.977 | -0.020 | 0.9985 | 79 | Beckman SYNCHRON
Uric Acid Reagent
(URIC) on the
SYNCHRON CX
System |
| Urine
SYNCHRON Uric
Acid Reagent
(URIC) on the
SYNCHRON LX
System | 0.995 | 0.116 | 0.9990 | 78 | Beckman SYNCHRON
Uric Acid Reagent
(URIC) on the
SYNCHRON CX
System |
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18 - 24
Linearity Study Results
| Analyte | Sample
Type | Option | Measuring Range | Assessment |
|---------------------|----------------|---------|------------------|------------|
| SYNCHRON
Systems | 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
4
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.
5
Page 2
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
6
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 Use
Optional Format 1-2-96 |
| ------------------------------------------ | ---- | ------------------------------------------------ |
|---|