(51 days)
SYNCHRON® CX® Systems BUN Reagent Kit, product no. 443350
Not Found
No
The 510(k) summary describes an in vitro diagnostic reagent for quantitative determination of urea nitrogen. There is no mention of AI or ML in the device description, intended use, or performance studies. The performance studies focus on precision and patient comparison using standard statistical methods, not AI/ML metrics.
No
This device is an in vitro diagnostic reagent used for the quantitative determination of urea nitrogen, not for treating a disease or condition.
Yes
Explanation: The device is a reagent intended for the quantitative determination of urea nitrogen, and the results are used in the treatment of numerous renal and metabolic diseases, which directly relates to diagnosing medical conditions.
No
The device is a reagent, which is a chemical substance used in a laboratory test. It is not a software-only medical device.
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 samples taken from the body.
- Device Description: The description reinforces that it's a "reagent" for determining a substance in biological fluids.
- Purpose: The results are used in the "treatment of numerous renal and metabolic diseases," indicating its use in a clinical context for diagnosis or monitoring.
The definition of an In Vitro Diagnostic device 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 fits the HiChem® BUN Reagent.
N/A
Intended Use / Indications for Use
HiChem® BUN Reagent is intended for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman® SYNCHRON CX® and CX® DELTA Systems.
Urea nitrogen results are used in the treatment of numerous renal and metabolic diseases.
This reagent is intended for professional use only.
Product codes
LFP
Device Description
Not Found
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
professional use only.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision:
Control sera and diluted urine pools were each assayed twice per day in triplicate using both HiChem® and Beckman® BUN reagents on a SYNCHRON CX® DELTA 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 described in NCCLS publication EP3-T.
Precision of BUN Recoveries (mgN/dL) for Serum 1 (mean 7.1): HiChem® Reagent - Within Run 1SD 0.65, Within Run %CV 9.1%, Total 1SD 0.66, Total %CV 9.4%. Beckman® Reagent - Within Run 1SD 0.65, Within Run %CV 9.1%, Total 1SD 0.60, Total %CV 8.4%. (n=60)
Precision of BUN Recoveries (mgN/dL) for Serum 2 (mean 35.4): HiChem® Reagent - Within Run 1SD 0.62, Within Run %CV 1.8%, Total 1SD 0.66, Total %CV 1.9%. Beckman® Reagent - Within Run 1SD 0.53, Within Run %CV 1.5%, Total 1SD 0.57, Total %CV 1.6%. (n=60)
Precision of BUN Recoveries (mgN/dL) for Serum 3 (mean 63.8): HiChem® Reagent - Within Run 1SD 0.50, Within Run %CV 0.8%, Total 1SD 0.80, Total %CV 1.3%. Beckman® Reagent - Within Run 1SD 0.72, Within Run %CV 1.1%, Total 1SD 0.76, Total %CV 1.2%. (n=60)
Precision of BUN Recoveries (mgN/dL) for Urine 1 (mean 21.7): HiChem® Reagent - Within Run 1SD 0.89, Within Run %CV 4.1%, Total 1SD 0.82, Total %CV 3.8%. Beckman® Reagent - Within Run 1SD 0.62, Within Run %CV 2.9%, Total 1SD 0.63, Total %CV 2.9%. (n=60)
Precision of BUN Recoveries (mgN/dL) for Urine 2 (mean 112.2): HiChem® Reagent - Within Run 1SD 0.75, Within Run %CV 0.7%, Total 1SD 1.25, Total %CV 1.1%. Beckman® Reagent - Within Run 1SD 0.82, Within Run %CV 0.7%, Total 1SD 1.31, Total %CV 1.2%. (n=60)
Precision of ORDAC BUN Recoveries (mgN/dL)
Serum 1 (mean 179): n=60, 1SD 1.18, %CV 0.7%, 1SD 2.58, %CV 1.4%
Serum 2 (mean 258): n=60, 1SD 1.91, %CV 0.7%, 1SD 3.55, %CV 1.4%
Patient Comparison:
Serum and plasma specimens, and urine specimens diluted with 9 parts normal saline, were collected from adult patients and analyzed with both HiChem® and Beckman® BUN reagents. Results were compared by least squares linear regression.
Serum/Plasma Comparison:
HiChem® = -0.3 mgN/dL + 0.987 x Beckman® Reagent
range = 4 - 126 mgN/dL r = 0.999 n = 160
Urine Comparison:
HiChem® = 0.9 mgN/dL + 0.979 x Beckman® Reagent
range = 6 - 142 mgN/dL r = 1.000 n = 79
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SYNCHRON® CX® Systems BUN Reagent Kit, product no. 443350
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.
0
OCT 14 1999
élan diagnostics
Image /page/0/Picture/3 description: The image shows the logo for "élan". The logo features a stylized letter "e" formed by several parallel lines that curve around to create the shape. To the left of the "e", there are a few short, horizontal lines that resemble the tail of a comet or a stylized wing. Below the symbol, the word "élan" is written in a sans-serif font, with an acute accent over the "e".
Summary of 510(k) Safety and Effectiveness Information
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
HiChem® BUN Reagent is intended for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman® SYNCHRON CX® and CX® DELTA Systems. The HiChem® BUN Reagent Kit is substantially equivalent to the SYNCHRON® CX® Systems BUN Reagent Kit, product no. 443350, manufactured by Beckman Coulter, Inc.
The effectiveness of the BUN Reagent Kit is shown by the following studies.
Precision:
Control sera and diluted urine pools were each assayed twice per day in triplicate using both HiChem® and Beckman® BUN reagents on a SYNCHRON CX® DELTA 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 described in NCCLS publication EP3-T.
Precision of BUN Recoveries (mgN/dL)
| Sample | n | mean | HiChem® Reagent | Beckman® Reagent | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Within Run | ||||||||||
| 1SD | Within Run | |||||||||
| %CV | Total | |||||||||
| 1SD | Total | |||||||||
| %CV | Within Run | |||||||||
| 1SD | Within Run | |||||||||
| %CV | Total | |||||||||
| 1SD | Total | |||||||||
| %CV | ||||||||||
| Serum 1 | 60 | 7.1 | 0.65 | 9.1% | 0.66 | 9.4% | 0.65 | 9.1% | 0.60 | 8.4% |
| Serum 2 | 60 | 35.4 | 0.62 | 1.8% | 0.66 | 1.9% | 0.53 | 1.5% | 0.57 | 1.6% |
| Serum 3 | 60 | 63.8 | 0.50 | 0.8% | 0.80 | 1.3% | 0.72 | 1.1% | 0.76 | 1.2% |
| Urine 1 | 60 | 21.7 | 0.89 | 4.1% | 0.82 | 3.8% | 0.62 | 2.9% | 0.63 | 2.9% |
| Urine 2 | 60 | 112.2 | 0.75 | 0.7% | 1.25 | 1.1% | 0.82 | 0.7% | 1.31 | 1.2% |
Two control sera were spiked with urea and assayed as described above using ORDAC sample dilution. Precision of ORDAC BUN Recoveries (mgN/dL)
| Sample | n | mean | 1SD | %CV | 1SD | %CV | n | mean | 1SD | %CV | 1SD | %CV |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Serum 1 | 60 | 179 | 1.18 | 0.7% | 2.58 | 1.4% | 60 | 180.0 | 1.18 | 0.7% | 2.17 | 1.2% |
| Serum 2 | 60 | 258 | 1.91 | 0.7% | 3.55 | 1.4% | 60 | 262.4 | 1.75 | 0.7% | 2.78 | 1.1% |
1
Patient Comparison
Serum and plasma specimens, and urine specimens diluted with 9 parts normal saline, were collected from adult patients and ാലിവി and plasma specifically, and anno opennance and Beckman® and Beckman® BUN reagents. Results were compared by least squares linear regression and the following statistics were obtained.
Serum/Plasma Comparison
HiChem® = -0.3 mgN/dL + 0.987 x Beckman® Reagent
range = 4 - 126 mgN/dL r = 0.999 n = 160
Urine Comparison
HiChem® = 0.9 mgN/dL + 0.979 x Beckman® Reagent range = 6 - 142 mgN/dL r = 1.000 n = 79
Wynn Jordan
Wynn Stocking Manager of Regulatory Affairs Elan Diagnostics
20 August, 1999
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and a wavy line representing water beneath it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 4 1999
Mr. Wynn Stocking Manager, Regulatory Affairs Elan Diagnostics 231 North Puente Street Brea. California 92821
Re: · K992847
Trade Name: HiChem® BUN Reagent Regulatory Class: II Product Code: LFP Dated: August 20, 1999 Received: August 24, 1999
Dear Mr. Stocking:
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 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). 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 (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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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.
3
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 regulation (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 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/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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
4
510(k) Number (if known):
Device Name:
HiChem® BUN Reagent
Indications For Use:
HiChem® BUN Reagent is intended for the quantitative determination of urea nitrogen in serum, plasma and urine on the Beckman® SYNCHRON CX® and CX® DELTA Systems.
Urea nitrogen results are used in the treatment of numerous renal and metabolic diseases.
This reagent is intended for professional use only.
Respectfully,
Wynn Stocking
Regulatory Affairs Manager Elan Diagnostics
20 August, 1999
Sean Cooper
(Division Sign-Off)
Division of Climate
Division of
510(k) Number: K971284
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use __
(Optional Format 1-2-96)
510(k) Notification, HiChem® BUN Reagent Elan Diagnostics, Brea, California
20 August, 1999 page 52 of 52