(51 days)
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.
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.
Here's a breakdown of the acceptance criteria and study details for the HiChem® BUN Reagent, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence are implied by the comparison to the predicate device (Beckman® SYNCHRON® CX® Systems BUN Reagent Kit). The study's goal was to demonstrate similar performance. The quantitative acceptance criteria are not explicitly stated as numerical thresholds (e.g., "within X% difference"), but rather through statistical comparisons like correlation coefficients (r) and differences in regression equations.
| Performance Metric | Acceptance Criteria (Implied - Similar to Predicate) | HiChem® Reagent Performance | Beckman® Reagent Performance (Predicate) | Device Meets Criteria? |
|---|---|---|---|---|
| Precision | Similar %CV and 1SD values to predicate | See detailed tables below | See detailed tables below | Yes |
| Serum 1 (7.1 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 9.1%, 9.4%, 0.65, 0.66 | 9.1%, 8.4%, 0.65, 0.60 | Yes (very similar) |
| Serum 2 (35.4 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 1.8%, 1.9%, 0.62, 0.66 | 1.5%, 1.6%, 0.53, 0.57 | Yes (very similar) |
| Serum 3 (63.8 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 0.8%, 1.3%, 0.50, 0.80 | 1.1%, 1.2%, 0.72, 0.76 | Yes (very similar) |
| Urine 1 (21.7 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 4.1%, 3.8%, 0.89, 0.82 | 2.9%, 2.9%, 0.62, 0.63 | Yes (similar) |
| Urine 2 (112.2 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 0.7%, 1.1%, 0.75, 1.25 | 0.7%, 1.2%, 0.82, 1.31 | Yes (very similar) |
| ORDAC Precision | Similar %CV and 1SD values to predicate | See detailed tables below | See detailed tables below | Yes |
| Serum 1 (179-180 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 0.7%, 1.4%, 1.18, 2.58 | 0.7%, 1.2%, 1.18, 2.17 | Yes (very similar) |
| Serum 2 (258-262.4 mgN/dL) | Within Run %CV, Total %CV, Within Run 1SD, Total 1SD similar to predicate | 0.7%, 1.4%, 1.91, 3.55 | 0.7%, 1.1%, 1.75, 2.78 | Yes (very similar) |
| Method Comparison (Serum/Plasma) | High correlation (r ≥ 0.99) and small intercept/slope deviation from 0/1 | r = 0.999, HiChem® = -0.3 + 0.987 * Beckman® | Not applicable (comparison) | Yes (very strong correlation, small bias) |
| Method Comparison (Urine) | High correlation (r ≥ 0.99) and small intercept/slope deviation from 0/1 | r = 1.000, HiChem® = 0.9 + 0.979 * Beckman® | Not applicable (comparison) | Yes (perfect correlation, small bias) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Precision Study:
- Serum/Urine Samples (non-ORDAC): For each of the 5 samples (3 serum, 2 urine), n = 60 (This represents 60 individual measurements for each sample type, collected over 10 days, assayed twice per day in triplicate).
- ORDAC Samples: For each of the 2 spiked serum samples, n = 60 (This represents 60 individual measurements for each sample type).
- Data Provenance: Not explicitly stated, but clinical laboratory studies often use control materials and patient samples from the country where the manufacturer is based (USA in this case, based on FDA submission). The study design (assaying twice per day over 30 days) suggests prospective data collection for the precision aspect.
- Patient Comparison (Method Comparison) Study:
- Serum/Plasma: n = 160
- Urine: n = 79
- Data Provenance: "collected from adult patients" - implies prospective collection of patient samples. Likely from the US, given the FDA submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This type of submission for a diagnostic reagent does not typically involve experts establishing a "ground truth" in the way an imaging or diagnostic AI model would. In in-vitro diagnostics, the "ground truth" is typically the quantitative result obtained from a reference method or the predicate device itself, which is assumed to be accurate.
Therefore, this section is not applicable for this device. The "ground truth" for comparison is the performance of the established, legally marketed predicate device (Beckman® SYNCHRON® CX® Systems BUN Reagent Kit).
4. Adjudication Method for the Test Set
Not applicable. There's no subjective interpretation requiring adjudication in a quantitative diagnostic assay comparison.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is a study comparing the performance of two quantitative diagnostic reagents, not a study involving human readers interpreting cases.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, in the sense that the device (reagent) performance itself is being evaluated and compared to a predicate, independent of human interpretation of the results. The "algorithm" here is the chemical reaction and analytical measurement process on the SYNCHRON CX® and CX® DELTA Systems. The reported performance metrics are purely analytical measurements of the reagent's characteristics.
7. The Type of Ground Truth Used
The ground truth or reference standard for comparison is the Beckman® SYNCHRON® CX® Systems BUN Reagent Kit. This is a well-established, legally marketed predicate device, and its performance is assumed to be the "gold standard" against which the new HiChem® BUN Reagent is evaluated for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is a diagnostic reagent, not an AI/ML model that requires a "training set." The development of the reagent itself would involve R&D and formulation, but not a "training set" in the computational sense.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no "training set" for this type of device.
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OCT 14 1999
élan diagnostics
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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 Run1SD | Within Run%CV | Total1SD | Total%CV | Within Run1SD | Within Run%CV | Total1SD | 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% |
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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
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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.
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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
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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
§ 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.