Mission BUN Reagent is intended for in vitro diagnostic use for the quantitative determination of urea nitrogen in serum, plasma, and urine on Beckman Synchron CX & CX® Delta Analyzers. BUN measurements are useful in the diagnosis and treatment of certain renal and metabolic diseases.

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. Mission uses a similar composition, description and packaging as that used by the OEM in its products.

AI/ML Overview

Acceptance Criteria and Device Performance for Mission Diagnostic BUN Reagent

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a separate section. However, the performance characteristics (precision, method comparison, and recovery) are compared against a predicate device, implying that performance similar to or better than the predicate is considered acceptable.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (Mission BUN Reagent)
Precision	CV% within acceptable ranges for clinical applications and comparable to predicate.	Serum Control 1 (13 mg/dL): Total CV = 5.8%
		Serum Control 2 (48 mg/dL): Total CV = 6.5%
		Urine Control 1 (58 mg/dL): Total CV = 3.3%
		Urine Control 2 (63 mg/dL): Total CV = 4.0%
Method Comparison (Serum)	Strong correlation ($r^2 \geq 0.99$), linear relationship, and minimal bias compared to predicate.	Equation: Mission = 0.892 x Beckman + 1.22
		Range: 4 to 87 mg/dL
		$r^2$: 0.997
		S(yx): 1.30 mg/dL
Method Comparison (Urine)	Strong correlation ($r^2 \geq 0.99$), linear relationship, and minimal bias compared to predicate.	Equation: Mission = 0.923 x Beckman + 1.054
		Range: 4 to 100 mg/dL
		$r^2$: 0.996
		S(yx): 1.70 mg/dL
Recovery to Expected Values (Serum)	Similar average % recovery to predicate across concentration ranges, ideally within 80-120%.	Range: 82 – 106%
		Overall Mean: 97%
Recovery to Expected Values (Urine)	Similar average % recovery to predicate across concentration ranges, ideally within 80-120%.	Range: 85.7 – 103.8%
		Overall Mean: 97.6%
Functional Sensitivity (Lowest level with <20% CV)	Comparable to or better than predicate device.	Mission reagent: 3 mg/dL
		Beckman reagent: 5 mg/dL

2. Sample Size and Data Provenance:

Precision:
- Sample Size: For each of the 4 controls (2 serum, 2 urine), 'N' = 80 observations. This was obtained by running samples for 20 days, 2 runs per day, and 2 observations per run (20 * 2 * 2 = 80).
- Data Provenance: Not explicitly stated, but based on the context of a new reagent being tested against a predicate, it is likely a prospective study conducted by Mission Diagnostics. No country of origin is specified.
Method Comparison:
- Serum: 'n' = 66 individual observations (derived from spiked/diluted samples run in triplicate).
- Urine: 'n' = 40 individual observations (derived from spiked/diluted samples run in triplicate).
- Data Provenance: Not explicitly stated, but likely prospective data collected by Mission Diagnostics. No country of origin is specified.
Recovery to Expected Values:
- Serum & Urine: Specific 'n' for individual recovery experiments not given, but refers to "Pooled Serum" and "Urine recovery samples" which were diluted and measured.
- Data Provenance: Not explicitly stated, but likely prospective data collected by Mission Diagnostics.
Functional Sensitivity:
- Sample Size: For each dilution, 'N' = 20 (4 samples per run over 5 calibrated runs).
- Data Provenance: Not explicitly stated, but likely prospective data collected by Mission Diagnostics.

3. Number of Experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is a diagnostic reagent for quantitative measurement of BUN, not an imaging or qualitative diagnostic device that requires expert interpretation for ground truth. The "ground truth" for the test set is established by the reference measurement from the predicate device and expected values from spiked/diluted samples.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No expert adjudication was involved as this is a quantitative chemical assay.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a chemical reagent, not an AI or imaging diagnostic device that relies on human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This study directly reports the "standalone" performance of the Mission BUN Reagent as a chemical assay. The performance is assessed against a predicate device rather than an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for this study is based on:

Reference measurements from the predicate device (Beckman BUN Reagent): Used for method comparison studies.
Expected values from gravimetrically spiked or diluted samples: Used for recovery studies.

8. The sample size for the training set:

Not applicable. This is a chemical reagent, not an AI or machine learning model that requires a training set. The "training" for the device, if any, would be the calibration process of the Beckman Synchron CX & CX® Delta Systems according to manufacturer instructions.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary

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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.

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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	TestMeanmg/dL	Swrwithin runsd	% CV	STTotalsd	%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

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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

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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

Page 1 of

510(k) K033056

Regulation Number and Section

§ 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.