(257 days)
Not Found
No
The device is a reagent for a laboratory analyzer and the description focuses on chemical composition and analytical performance metrics, with no mention of AI/ML.
No.
The device is a reagent used for quantitative determination of urea nitrogen to aid in diagnosis, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "to aid in the diagnosis of renal function and pre renal disease states."
No
The device description explicitly states it is a reagent, which is a chemical substance used in a laboratory test, not a software program.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of urea nitrogen in serum, plasma and urine". These are biological specimens taken from the human body.
- Purpose: The purpose is to "aid in the diagnosis of renal function and pre renal disease states". This clearly indicates a diagnostic purpose.
- Device Description: It's a "reagent" used on a laboratory analyzer (Beckman SYNCHRON CX3® System) to perform the test. Reagents used for testing biological samples for diagnostic purposes are a core component of IVDs.
The definition of an In Vitro Diagnostic (IVD) is a medical device that is used to perform tests on samples such as blood, urine, or tissue, to detect diseases or other conditions. This description perfectly aligns with the information provided for the BUN Reagent.
N/A
Intended Use / Indications for Use
The BUN Reagent is to be used for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman SYNCHRON CX3® System to aid in the diagnosis of renal function and pre renal disease states, such as cardiac decompensation and others.
Product codes
CDS
Device Description
The Device is a reagent containing sufficient Urease, surfactants and other ingredients necessary for optimum system operation on the Beckman Synchron CX3® Analyzer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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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
Precision/Reproducibility: Control sera and diluted urine pools were each assaved twice per day in triplicate on a SYNCHRON CX3® System. Data were collected on ten different days over a thirty day period. Estimates of within run and total imprecision were calculated analogous to the method in NCCLS publication EP3-T.
Linearity/assay reportable range: Linearity was performed according to NCCLS Guideline EP6-A. Commercially available linearity standards ranging from 0 to 158 mg/dl were analyzed in triplicate on the Beckman CX3® and the results analyzed by the Least Squares method. The results gave a slope of 0.995 with an intercept of -0.12, a standard error of estimate of 0.49 and re = 1.00.
Sensitivity: The sensitivity of this method is 2 mg/dL and is documented through the repetitive assay of a diluted serum control. The observed sensitivity limit, calculated as three standard deviations of a 21 replicate within run precision study, is 1.43 mg/dL and is below the claimed limit of 2 mg/dL.
Analytical Specificity: Determined according to NCCLS EP7-A. Hemoglobin levels up to 500 mg/dL, Bilirubin levels up to 20 mg/dL, and Lipemia levels up to 1800 mg/dL were tested and did not show any adverse effect on a stock sample with a BUN level of 15 mg/dL.
Patient Comparison: Serum and plasma specimens, and urine specimens diluted with 9 parts normal saline, ranging from 4 to 300 mg/dL were collected from adult patients and assayed for urea nitrogen on a SYNCHRON CX3® System using GenChem and Beckman BUN reagents. Results were compared by least squares linear regression.
Results for Patient Comparison:
Serum (n=80): Intercept -0.3, Slope 0.995, R2 Value 0.999, Range 4-300
Plasma (n=80): Intercept -0.2, Slope 0.989, R2 Value 0.998, Range 4-300
Urine (n=79): Intercept 0.9, Slope 0.979, R2 Value 1.000, Range 6-142
Key Metrics
Precision/Reproducibility:
Serum 1 (n=60, mean=7.1): Within Run 1SD=0.65, %CV=9.1; Total Imprecision 1SD=0.66, %CV=9.4
Serum 2 (n=60, mean=35.4): Within Run 1SD=0.62, %CV=1.8; Total Imprecision 1SD=0.66, %CV=1.9
Serum 3 (n=60, mean=63.8): Within Run 1SD=0.50, %CV=0.8; Total Imprecision 1SD=0.80, %CV=1.3
Urine 1 (n=60, mean=21.7): Within Run 1SD=0.89, %CV=4.1; Total Imprecision 1SD=0.82, %CV=3.8
Urine 2 (n=60, mean=112.2): Within Run 1SD=0.75, %CV=0.7; Total Imprecision 1SD=1.25, %CV=1.1
Linearity: Slope = 0.995, Intercept = -0.12, Standard error of estimate = 0.49, r = 1.00
Sensitivity: 2 mg/dL, Observed sensitivity limit (3 SD) = 1.43 mg/dL
Analytical Specificity: Hemoglobin levels up to 500 mg/dL, Bilirubin levels up to 20 mg/dL, Lipemia levels up to 1800 mg/dL showed no adverse effect on 15 mg/dL BUN sample.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1770 Urea nitrogen test system.
(a)
Identification. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.(b)
Classification. Class II.
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DEC 27 2004
510(k) SUMMARY K040973
1.0 Submitted By:
C.C. Allain, Ph.D. Chief Scientific Officer GenChem, Inc. 471 W. Lambert Road, Ste 107 Brea, CA 92821 Telephone: (714) 529-7125 FAX: (714) 529-3339
June 1, 2004 2.0 Date of Preparation:
3.0 Regulatory Information:
- 3.1 Regulation section:
- 3.2 21 CFR § 862.1770, Electrode, Ion Specific, Urea Nitrogen for Beckman Synchron CX3® System
- 3.3 Clasification : Class II
- Product Code: CDS 3.4
- 3.5 Panel: Clinical Chemistry (75)
4.0 Device Description:
The Device is a reagent containing sufficient Urease, surfactants and other ingredients necessary for optimum system operation on the Beckman Synchron CX3® Analyzer.
5.0 Substantial Equivalence Information:
- Predicate Device Name: a.
b.
Beckman BUN reagent for the CX3.
c. Predicate K number:
Comparison with predicate: The two products have the same intended use, C. utilize the conductivity reactions on the same instrument, have the same analytical range, have the same stability
- 6.0 Performance Characteristics: All studies were performed on the Beckman CX3® Synchron Analyzer
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Precision/Reproducibility: 6.1
Control sera and diluted urine pools were each assaved twice per day in triplicate on a SYNCHRON CX3® System. Data were collected on ten different days over a thirty day period. Estimates of within run and total imprecision were calculated analogous to the method in NCCLS publication EP3-T.
| Sample | n | mean | Within Run | Total Imprecision | |||
|---|---|---|---|---|---|---|---|
| 1SD | %CV | 1SD | %CV | ||||
| Serum 1 | 60 | 7.1 | 0.65 | 9.1 | 0.66 | 9.4 | |
| Serum 2 | 60 | 35.4 | 0.62 | 1.8 | 0.66 | 1.9 | |
| Serum 3 | 60 | 63.8 | 0.50 | 0.8 | 0.80 | 1.3 | |
| Urine 1 | 60 | 21.7 | 0.89 | 4.1 | 0.82 | 3.8 | |
| Urine 2 | 60 | 112.2 | 0.75 | 0.7 | 1.25 | 1.1 |
Precision of BUN Recoveries in (maN/dL)
6.2 Linearity/assay reportable range:
Linearity was performed according to NCCLS Guideline EP6-A. Commercially available linearity standards ranging from 0 to 158 mg/dl were analyzed in triplicate on the Beckman CX3® and the results analyzed by the Least Squares method. The results gave a slope of 0.995 with an intercept of -0.12, a standard error of estimate of 0.49 and re = 1.00 and is shown below. Specimens exceeding these limits should be diluted with normal saline and reanalyzed. Multiply the result by the appropriate dilution factor.
| Specimens | Range | Conventional Units | SI Units |
|---|---|---|---|
| All | Normal | 2 - 150 mgN/dL | 2-53.6mmol/L |
| All | ORDAC* | 150 - 300 mgN/dL | 53-107.2mmol/L |
6.3 SENSITIVITY:
The sensitivity of this method is 2 mg/dL and is documented through the repetitive assay of a diluted serum control. The observed sensitivity limit, calculated as three standard deviations of a 21 replicate within run precision study, is 1.43 mg/dL and is below the claimed limit of 2 mg/dL.
6.4 Analytical Specificity:
Determined according to NCCLS EP7-A. Hemoglobin levels up to 500 mg/dL, Bilirubin levels up to 20 mg/dL, and Lipemia levels up to 1800 mg/dL were tested and did not show any adverse effect on a stock sample with a BUN level of 15 mg/dL. Stock solutions
2
of the substance to be tested were prepared at 20x concentrations and 0.5 ml of this stock was placed in a 10 ml volumetric flask and made up to volume with the base pool. The control stock was prepared similarly but with water as the diluent. Heparin, Lithium Heparin Ammonium Heparin, and EDTA are acceptable anticoagulants.
7.0
Patient Comparison
Serum and plasma specimens, and urine specimens diluted with 9 parts normal saline, ranging from 4 to 300 mg/dL were collected from adult patients and assayed for urea nitrogen on a SYNCHRON CX3® System using GenChem and Beckman BUN reagents. Results were compared by least squares linear regression and the following statistics were obtained:
| VALUE | SERUM | PLASMA | URINE |
|---|---|---|---|
| Intercept | -0.3 | -0.2 | 0.9 |
| Slope | 0.995 | 0.989 | 0.979 |
| R2 Value | 0.999 | 0.998 | 1.000 |
| N | 80 | 80 | 79 |
| Range | 4-300 | 4-300 | 6-142 |
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The seal is simple and monochromatic.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 27 2004
C.C. Allain, Ph.D. Chief Scientific Officer GenChem, Inc. 471 W. Lambert Road, Suite 107 Brea, CA 92821
Re: K040973
Trade/Device Name: Electrode, Ion Specific, Urea Nitrogen (BUN) Reagent Regulation Number: 21 CFR 862.1770 Regulation Name: Urea nitrogen test system Regulatory Class: Class II Product Code: CDS Dated: October 15, 2004 Received: October 15, 2004
Dear Dr. Allain:
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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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.
Cornelia B. Lorks
Cornelia B. Rooks, MA Acting 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: K040973
Device Name: Electrode, Ion Specific, Urea Nitrogen (BUN) Reagent
Indications For Use:
The BUN Reagent is to be used for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman SYNCHRON CX3® System to aid in the diagnosis of renal function and pre renal disease states, such as cardiac decompensation and others.
Alberto Salsi
Office of In Vitro Diagnost Device Evaluation an
510k K040973
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)