(123 days)
No
The device description and performance studies focus on enzymatic conductivity methods and standard statistical analysis, with no mention of AI or ML.
No
This device is an in vitro diagnostic reagent used to quantitatively measure urea nitrogen in samples, aiding in diagnosis, not directly treating a disease.
Yes
Explanation: The device is intended for "in vitro diagnostic use for the quantitative determination of urea nitrogen in serum, plasma, and urine." It states that "BUN measurements are useful in the diagnosis and treatment of certain renal and metabolic diseases." These phrases directly indicate its use in disease diagnosis.
No
The device is a reagent used with a specific analyzer, which is a hardware component. The description focuses on the chemical and enzymatic properties of the reagent and its performance in laboratory tests, not on software functionality.
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 Mission BUN Reagent is "intended for in vitro diagnostic use".
- Purpose: It is used for the "quantitative determination of urea nitrogen in serum, plasma, and urine", which are biological samples tested outside of the body.
- Clinical Relevance: The results are used to aid in the "diagnosis and treatment of certain renal and metabolic diseases".
These points clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Mission BUN Reagent is intended for in vitro diagnostic use for the quantitative deterningtion of . Mission BON Reagent is thenaculer in the allaghesis and urine on Beckman Synchron CX & CX® Delta Analyzers.
- BUN measurements are useful in the diagnosis and treatment of certain renal and metabolic diseases
Product codes (comma separated list FDA assigned to the subject device)
CGA, CDS
Device Description
- Urea nitrogen concentration is determined by an enzymatic conductivity method employing a . Beckman Conductivity Electrode. Electronic circuits determine the rate of increase in conductivity, which is directly proportional to the concentration of BUN in the sample.
- The original equipment manufacturer (OEM) of the instruments and the predicate reagents . which are necessary for the continued operation and use of the instruments.
- Mission uses a similar composition, description and packaging as that used by the OEM in its t products, as shown in the packaging section of this submission.
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
Not Found
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 data was collected following the guidelines of NCCLS Guideline EP5-A. Samples were run for 20 days, 2 runs per day, 2 observations per run on an instrument operated according to the manufacturers instructions.
Method Comparison of Mission BUN Reagent to Beckman Reagent following the guidelines of NCCLS Guideline EP9-A2 was conducted. Serum samples were spiked or diluted and run in triplicate and tested with each reagent, Mission BUN Reagent and Beckman BUN Reagent in separate calibrated runs. Recoveries of individual observations were compared by least squares regression. Urine controls were spiked or diluted and run in triplicate and tested with each reagent, Mission BUN Reagent and Beckman BUN Reagent in separate calibrated runs. Recoveries of individual observations were compared by least squares regression.
Recovery to Expected Values was evaluated for each matrix; serum & urine. Dilutions of the respective matrices were made and measured with Mission and Beckman reagent. Pooled Serum was spiked to an expected value of 200 mg/dL by adding urea gravimetrically. Dilutions were made using the spiked serum, serum, and/or Human serum albumin (HmSA). Urine recovery samples were made by mixing Urine Control 2 (expected value = 300 mg/dL), Urine Control 1 (expected value = 135 mg/dL), and/or Normal saline.
Functional sensitivity was evaluated on dilutions of serum samples made from a starting serum of I uncilentif oncentration of 13.7 mg/dL; and dilutions of 1:3, 1:5.1:11 and a zero. Dilutions were tested as 4 samples per run over 5 calibrated runs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision:
Serum Control 1: N=80, Mean=13 mg/dL, Swr=0.7 sd, %CV=5.5, ST=0.7 sd, %CV=5.8
Serum Control 2: N=80, Mean=48 mg/dL, Swr=1.3 sd, %CV=2.7, ST=3.1 sd, %CV=6.5
Urine Control 1: N=80, Mean=58 mg/dL, Swr=1.2 sd, %CV=2.1, ST=1.9 sd, %CV=3.3
Urine Control 2: N=80, Mean=63 mg/dL, Swr=1.9 sd, %CV=2.9, ST=2.6 sd, %CV=4.0
Method Comparison:
Serum: Mission = 0.892 x Beckman + 1.22, Range = 4 to 87 mg/dL; r2 = 0.997; df = 65; n = 66; S(yx) = 1.30 mg/dL
Urine: Mission = 0.923 x Beckman + 1.054, Range = 4 to 100 mg/dL; r2 = 0.996; df = 41; n = 40; S(yx) = 1.70 mg/dL
Recovery to Expected Values:
Serum (81.0 – 7.5 mg/dL): Mission Range of average % Recovery = 82 – 106, Overall Mean Recovery = 97; Beckman Range of average % Recovery = 94 – 111, Overall Mean Recovery = 105
Urine (100 – 10.5 mg/dL): Mission Range of average % Recovery = 85.7 – 103.8, Overall Mean Recovery = 97.6; Beckman Range of average % Recovery = 93.3 – 110, Overall Mean Recovery = 101.2
Functional Sensitivity (% CV
§ 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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K033056
Page 2 of 4
JAN 3 0 2004
510(k) Summary for Mission Diagnostic BUN Reagent for Beckman Synchron CX® & CX® Delta Systems
Submitter's Name & Address 1.
Mission Diagnostics 331 Fiske St Holliston MA 01746 FAX: 508-429-0452
Contact Person: Linda Stundtner QA/RA Manager
508-429-0450
3003656721 Establishment Registration Number:
Date of Preparation:
Jan 19, 2004
2. Identification of the Device:
| Proprietary/Trade name: | BUN Reagent for Beckman Synchron CX & Delta Instrument |
|---|---|
| Common or usual name | BUN Reagent |
| Classification name: | Urea Nitrogen test system |
| Device Classification | II |
| Regulation Number: | 21 CFR § 862.1345 |
| Panel: | Chemistry (75) |
| Product Code: | CGA |
- Mission manufactures reagents intended to serve as direct replacements to like named products . manufactured by Original Equipment Manufactures (OEM)
Predicate Device: 3.
- Mission claims substantial equivalence to the OEM Reagent listed below: .
Substantial Equivalence Table of Product PN & Trade Names
| Mission Product | OEM Equivalent |
|---|---|
| BK-443350D BUN Reagent | 443350 BUN Reagent |
- The predicate reagent, Beckman PN 443350, is encompassed in the 510(k)'s K942676 & . K864236 cleared 11/02/1994 & 12/31/1986 respectively.
4. Device Description:
- Urea nitrogen concentration is determined by an enzymatic conductivity method employing a . Beckman Conductivity Electrode. Electronic circuits determine the rate of increase in conductivity, which is directly proportional to the concentration of BUN in the sample.
Intended Use:
- Mission BUN Reagent is intended for the quantitative determination of urea nitrogen in . serum, plasma, and urine on Beckman Synchron CX & Delta Analyzers.
- BUN measurements are used in the diagnosis and treatment of certain renal and . metabolic diseases.
1
- The original equipment manufacturer (OEM) of the instruments and the predicate reagents . which are necessary for the continued operation and use of the instruments.
- Mission uses a similar composition, description and packaging as that used by the OEM in its t products, as shown in the packaging section of this submission.
5. Performance Characteristics:
Precision and correlation data are collected per:
- SOP23-01-02 Performance Study Protocol for 510(k) Submission .
Precison and Correlation are summarized below:
Precision data was collected following the guidelines of NCCLS Guideline EP5-A
- Samples were run for 20 days, 2 runs per day, 2 observations per run on an instrument ● operated according to the manufacturers instructions. The following data was obtained:
| | N | Test
Mean
mg/dL | Swr
within run
sd | % CV | ST
Total
sd | %CV |
|-----------------|----|-----------------------|-------------------------|------|-------------------|-----|
| Serum Control 1 | 80 | 13 | 0.7 | 5.5 | 0.7 | 5.8 |
| Serum Control 2 | 80 | 48 | 1.3 | 2.7 | 3.1 | 6.5 |
| Urine Control 1 | 80 | 58 | 1.2 | 2.1 | 1.9 | 3.3 |
| Urine Control 2 | 80 | 63 | 1.9 | 2.9 | 2.6 | 4.0 |
Method Comparison of Mission BUN Reagent to Beckman Reagent following the guidelines of NCCLS Guideline EP9-A2 was conducted.
Serum samples were spiked or diluted and run in triplicate and tested with each reagent, Mission BUN Reagent and Beckman BUN Reagent in separate calibrated runs. Recoveries of individual observations were compared by least squares regression. The following statistics were obtained:
Mission = 0.892 x Beckman + 1.22 Range = 4 to 87 mg/dL; r2 = 0.997; df = 65; n = 66; Sqxx) = 1.30 mg/dL
Urine controls_were spiked or diluted and run in triplicate and tested with each reagent, Mission BUN Reagent and Beckman BUN Reagent in separate calibrated runs. Recoveries of individual observations were compared by least squares regression. The following statistics were obtained:
Mission = 0.923 x Beckman + 1.054 Range = 4 to 100 mg/dL; r2 = 0.996; df = 41; n = 40; S(yx) = 1.70 mg/dL
Recovery to Expected Values was evaluated for each matrix; serum & urine. Dilutions of the respective matrices were made and measured with Mission and Beckman reagent.
- Pooled Serum was spiked to an expected value of 200 mg/dL by adding urea gravimetrically. Dilutions . were made using the spiked serum, serum, and/or Human serum albumin (HmSA).
- Urine recovery samples were made by mixing Urine Control 2 (expected value = 300 mg/dL), Urine . Control 1 (expected value = 135 mg/dL), and/or Normal saline.
% Recovery = (Measured/expected) x100 was calculated for both Mission and Beckman. Mission and Beckman exhibited similar recoveries across the range of values in all matrices. See table below:
| Matrix | Range of Conc. Expected, mg/dL | Reagent | Range of average % Recovery | Overall Mean Recovery |
|---|---|---|---|---|
| Serum | 81.0 – 7.5 mg/dL | Mission | 82 – 106 | 97 |
| Serum | 81.0 – 7.5 mg/dL | Beckman | 94 – 111 | 105 |
| Urine | 100 – 10.5 mg/dL | Mission | 85.7 – 103.8 | 97.6 |
| Urine | 100 – 10.5 mg/dL | Beckman | 93.3 – 110 | 101.2 |
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Functional sensitivity was evaluated on dilutions of serum samples made from a starting serum of I uncilentif oncentration of 13.7 mg/dL; and dilutions of 1:3, 1:5.1:11 and a zero. Dilutions were tested as 4 samples per run over 5 calibrated runs.
- The lowest level where the % CV was less than 20% was with the dilution at an expected . value of 3 mg/dL BUN which measured/recovered as:
- 3 mg/dL with Mission reagent .
- . 5 mg/dL with Beckman reagent.
The CX Delta reports BUN values to the whole number.
| Mission Reagent | Beckman Reagent | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Dilution | Expected value mg/dL | Mean | sd | N | %CV | Mean | sd | N | %CV |
| 1 | 13.7 | 14.1 | 0.60 | 20 | 4.3 | 15.1 | 1.52 | 20 | 10.1 |
| 2 | 4.6 | 5.1 | 0.22 | 20 | 4.4 | 6.4 | 0.50 | 20 | 7.9 |
| 3 | 2.7 | 3.1 | 0.22 | 20 | 7.3 | 4.6 | 0.50 | 20 | 10.9 |
| 4 | 0.7 | 1.0 | 0.56 | 20 | 56.2 | 3.0 | 0.97 | 20 | 32.4 |
| 5 | 0.0 | 0.5 | 0.71 | 2 | 141.4 | NA | NA | 0 | NA |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/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 tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Linda M. Stundtner QA/RA Manager Diamond Diagnostics Mission Diagnostics Division 331 Fiske St. Holliston. MA 01746
JAN $ 0 2004
K033056 Re:
Trade/Device Name: Mission Diagnostic BUN Reagent for Beckman Synchron CX & CX® Delta Systems
Regulation Number: 21 CFR 862.1770 Regulation Name: Urea nitrogen test system Regulatory Class: Class II Product Code: CDS Dated: December 22, 2003 Received: December 24, 2003
Dear Ms. Stundtner:
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 ror woo waver 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 If your de roo is one 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 r reaso of a reade 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 or unly 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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Page 2
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,
Jean M. Cooper, MS, DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name Mission Diagnostic BUN Reagent for Beckman Synchron CX & CX Delta Systems
Indications For Use:
- Mission BUN Reagent is intended for in vitro diagnostic use for the quantitative deterningtion of . Mission BON Reagent is thenaculer in the allaghesis and urine on Beckman Synchron CX & CX® Delta Analyzers.
- BUN measurements are useful in the diagnosis and treatment of certain renal and metabolic � diseases
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Carol C. Benam for Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k) K033056