Predicate Devices

704092, 67-UV

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a chemical reagent and its enzymatic reaction for quantitative analysis, with no mention of AI or ML technologies.

Therapeutic

No.
This device is described as a reagent for the quantitative determination of urea nitrogen in biological samples, indicating it is an in vitro diagnostic (IVD) product used for diagnostic purposes, not for treating a disease or condition.

Diagnostic

Yes

Explanation: The device is intended for the "quantitative determination of urea nitrogen in serum, plasma and urine," which is a measurement used to aid in diagnosing conditions related to kidney function and metabolism.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a reagent, which is a chemical substance used in a chemical reaction, not software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "for the quantitative determination of urea nitrogen in serum, plasma and urine." This clearly indicates that the device is used to test samples taken from the human body (serum, plasma, urine) to provide information about a person's health status (urea nitrogen levels).
Device Description: The description details a reagent used in a laboratory setting to perform a chemical reaction on a biological sample. This is characteristic of an in vitro diagnostic device.
Intended User / Care Setting: The intended user is "clinical analyzers," which are instruments used in clinical laboratories to perform diagnostic tests. This further supports its use in a diagnostic context.
Performance Studies: The document describes performance studies involving testing of biological samples (serum, plasma, urine) and comparison to predicate devices, which are standard practices for validating IVD devices.

All these elements align with the definition of an In Vitro Diagnostic device, which is a medical device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

HiChem BUN/Urea Reagent (product no. 70006) is for the quantitative determination of urea nitrogen in serum. plasma and urine. Plasma urea levels are affected by a wide variety of factors including diet, increased protein catabolism and mild dehydration as well as many renal diseases. The major value of plasma urea measurement is in distinguishing between renal and non-renal related causes.

Product codes

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Device Description

The HiChem BUN/Urea Reagent determines urea nitrogen through enzymatic hydrolysis by urease. The rate of this reaction, and the quantity of urea nitrogen in the specimen is monitored through the measurement of the resulting ammonia which oxidizes NADH to NAD in the presence of ox-keto-glutarate and glutamate dehydrogenase.

The HiChem BUN/Urea Reagent is intended to be used with the HiChem Chemistry Standard, product no. 70023 or other compatible NIST traceable calibration standard either as a manual procedure or on clinical analyzers which can automate the required manipulations. The reagent is supplied as two liquid-stable reagent components which are intended to be combined, either before or during use, in the approximate ratio of 1 part BUN/Urea Enzyme Reagent and 5 parts BUN/Urea Buffer. The BUN/Urea Enzyme Reagent can also be used as a start reagent and combined with the reagent buffer after sample addition.

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

The effectiveness of the manual procedure is shown by the recovery of linearity standards, the precision of control recoveries, a comparison of serum and plasma recoveries to the Sigma BUN (Rate) Reagent and a comparison of urine recoveries to the BMD BUN Reagent.

The effectiveness of the automated Hitachi 704 procedure is shown by the precision of control recoveries, the recovery of linearity standards, and comparison of mixed serum and urine recoveries to the BMD BUN Reagent.

Key Metrics

Precision, demonstrated by replicate assay of commercially available control sera and urine pools, is shown below.

Specimen	n	mean	within run SD	total SD
Low serum control	30	8.7 mgN/dL	0.48 mgN/dL	0.58 mgN/dL
Mid. serum control	30	25.7 mgN/dL	0.73 mgN/dL	0.70 mgN/dL
High serum control	30	52.1 mgN/dL	0.93 mgN/dL	1.02 mgN/dL
Low urine pool	30	15.4 mgN/dL	0.71 mgN/dL	0.90 mgN/dL
High urine pool	30	53.3 mgN/dL	1.20 mgN/dL	1.54 mgN/dL

The recovery of urea nitrogen using HiChem BUN/Urea Reagent as a manual method is linear to at least 150 mgN/dL as shown by the recovery of linearity standards which span the claimed linear range. Regression statistics are shown below.

(HiChem Results) = 0.1 mgN/dL + 0.986 × (Standard Value), r2 = 1.000, Sy.x = 0.5 mgN/dL.

Urea nitrogen recoveries of 80 mixed serum and plasma specimens are compared between the HiChem and Sigma reagents. Urea nitrogen recoveries of 39 urine specimens diluted with 20 parts normal saline are compared between the HiChem BUN/Urea Reagent and the BMD BUN Reagent used on the Hitachi 704. All reagents were calibrated with their recommended calibrators. Least squares regression statistics are shown below.

Serum/Plasma Comparison
(HiChem Results) = 0.7 mgN/dL + 0.977 × (Sigma Results)	r2 = 0.996, Sy.x = 1.00 mgN/dL
Urine Comparison
(HiChem Results) = 1.9 mgN/dL + 0.966 × (BMD Results)	r2 = 0.990, Sy.x = 1.82 mgN/dL

The use of sodium and lithium heparin, EDTA, citrate, and iodoacetate are also shown to be acceptable chemical additives by comparison of spiked and unspiked serum pools. In all cases observed were less than 1% and statistically insignificant.

The stability of the combined working reagent over 1 month at 2-8°C and 4 days at 18-25°C are documented through the recovery of linearity standards which span the claimed linear range of the method. In all cases, the observed shifts in standard recovery were less than the greater of 3 mgN/dL or 3%.

Precision, demonstrated by replicate assay of commercially available control sera and urine pools, is shown below.

Specimen	n	mean	within run SD	total SD
Low serum control	60	13.9 mgN/dL	0.59 mgN/dL	0.81 mgN/dL
Mid. serum control	60	52.7 mgN/dL	0.60 mgN/dL	0.77 mgN/dL
High serum control	60	78.8 mgN/dL	0.70 mgN/dL	1.09 mgN/dL
Low urine pool	60	21.9 mgN/dL	0.54 mgN/dL	0.52 mgN/dL
High urine pool	60	75.3 mgN/dL	0.85 mgN/dL	2.91 mgN/dL

The recoveries of urea nitrogen standards, which span the claimed linear range of 0 to 150 mgN/dL, are equivalent between the HiChem and BMD BUN Reagents. Regression statistics are shown below.

(HiChem Results) = 0.0 mgN/dL + 1.005 x (BMD Results), r2 = 1.000, Sy.x = 0.6 mgN/dL.

Urea nitrogen recoveries of 190 mixed serum and plasma specimens diluted with 20 parts normal saline compared between the HiChem and BMD reagents using least squares regression, yield the following statistics.

Serum/Plasma Comparison

(HiChem Results) = 0.0 mgN/dL + 1.009 × (BMD Results) r2 = 0.999 . Sy.x = 0.6 mgN/dL.

Urine Comparison (HiChem Results) = 0.1 mgN/dL + 1.027 × (BMD Results) r2 = 0.999. Sv.x = 0.7 mgN/dL.

The calibration stability claim of 48 hours is documented through the recovery of serum controls which span from 8 to 132 mgNdL urea nitrogen. In all cases, the observed shifts in recoveries over the calibration period are less than the greater of 2 mgN/dL or 2%.

Predicate Device(s)

BMD BUN Reagent, product no. 704092, Sigma BUN (Rate) Reagent, procedure no. 67-UV

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

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KSC0115

MAR 2 9 1996

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/Urea Reagent (product no. 70006) is for the quantitative determination of urea nitrogen in serum. plasma and urine. Plasma urea levels are affected by a wide variety of factors including diet, increased protein catabolism and mild dehydration as well as many renal diseases. The major value of plasma urea measurement is in distinguishing between renal and non-renal related causes.

The HiChem BUN/Urea Reagent determines urea nitrogen through enzymatic hydrolysis by urease. The rate of this reaction, and the quantity of urea nitrogen in the specimen is monitored through the measurement of the resulting ammonia which oxidizes NADH to NAD in the presence of ox-keto-glutarate and glutamate dehydrogenase.

The HiChem BUN/Urea Reagent is intended to be used with the HiChem Chemistry Standard, product no. 70023 or other compatible NIST traceable calibration standard either as a manual procedure or on clinical analyzers which can automate the required manipulations. The reagent is supplied as two liquid-stable reagent components which are intended to be combined, either before or during use, in the approximate ratio of 1 part BUN/Urea Enzyme Reagent and 5 parts BUN/Urea Buffer. The BUN/Urea Enzyme Reagent can also be used as a start reagent and combined with the reagent buffer after sample addition.

The HiChem BUN/Urea Reagent calibrated with the HiChem Chemistry Standard, product 70023 is substantially equivalent to the BMD BUN Reagent, product no. 704092 calibrated with Precical Calibrator Serum and Diluent. product no. 620213, both manufactured by Boehringer Mannheim Corp., Indianapolis, IN. and the Sigma BUN (Rate) Reagent, procedure no. 67-UV calibrated with Glucose/Urea Nitrogen Standard, product no. 16-300, both manufactured by Sigma Diagnostics, St. Louis, MO. Substantial equivalence between the HiChem and other calibrators for the purpose of calibrating urea nitrogen methods is also shown. All three reagent/calibrator pairs support the same intended use (with the exception of the specimen limitations for the Sigma reagent) and produce equivalent results with the same clinical purpose. In addition, they are all based on the same methodology which determines urea nitrogen through the rate of NADH depletion. Finally, all reagents are sold in a generic format with their use on various instruments supported through procedure supplements (application sheets).

The effectiveness of the manual procedure is shown by the recovery of linearity standards, the precision of control recoveries, a comparison of serum and plasma recoveries to the Sigma BUN (Rate) Reagent and a comparison of urine recoveries to the BMD BUN Reagent.

Precision, demonstrated by replicate assay of commercially available control sera and urine pools, is shown below.

Specimen	n	mean	within run SD	total SD
Low serum control	30	8.7 mgN/dL	0.48 mgN/dL	0.58 mgN/dL
Mid. serum control	30	25.7 mgN/dL	0.73 mgN/dL	0.70 mgN/dL
High serum control	30	52.1 mgN/dL	0.93 mgN/dL	1.02 mgN/dL
Low urine pool	30	15.4 mgN/dL	0.71 mgN/dL	0.90 mgN/dL
High urine pool	30	53.3 mgN/dL	1.20 mgN/dL	1.54 mgN/dL

The recovery of urea nitrogen using HiChem BUN/Urea Reagent as a manual method is linear to at least 150 mgN/dL as shown by the recovery of linearity standards which span the claimed linear range. Regression statistics are shown below.

(HiChem Results) = 0.1 mgN/dL + 0.986 × (Standard Value), r2 = 1.000, Sy.x = 0.5 mgN/dL.

Urea nitrogen recoveries of 80 mixed serum and plasma specimens are compared between the HiChem and Sigma reagents. Ureanittogen recoveries of 39 urine specimens diluted with 20 parts normal saline are compared between the HiChem BUN/Urea Reagent and the BMD BUN Reagent used on the Hitachi 704. All reagents were calibrated with their recommended calibrators. Least squares regression statistics are shown below. .: I.AN

Diagnostics Division

HiChem

231 North Puente Street, Brea, California 92621 Telephone: (714) 871-8360 / (800) 422-3526 / Fax: (714) 871-2439

1

Serum/Plasma Comparison
(HiChem Results) = 0.7 mgN/dL + 0.977 × (Sigma Results)	r2 = 0.996, Sy.x = 1.00 mgN/dL
Urine Comparison
(HiChem Results) = 1.9 mgN/dL + 0.966 × (BMD Results)	r2 = 0.990, Sy.x = 1.82 mgN/dL

The use of sodium and lithium heparin, EDTA, citrate, and iodoacetate are also shown to be acceptable chemical additives by comparison of spiked and unspiked serum pools. In all cases observed were less than 1% and statistically insignificant.

The stability of the combined working reagent over 1 month at 2-8°C and 4 days at 18-25°C are documented through the recovery of linearity standards which span the claimed linear range of the method. In all cases, the observed shifts in standard recovery were less than the greater of 3 mgN/dL or 3%.

The effectiveness of the automated Hitachi 704 procedure is shown by the precision of control recoveries, the recovery of linearity standards, and comparison of mixed serum and urine recoveries to the BMD BUN Reagent.

Precision, demonstrated by replicate assay of commercially available control sera and urine pools, is shown below.

Specimen	n	mean	within run SD	total SD
Low serum control	60	13.9 mgN/dL	0.59 mgN/dL	0.81 mgN/dL
Mid. serum control	60	52.7 mgN/dL	0.60 mgN/dL	0.77 mgN/dL
High serum control	60	78.8 mgN/dL	0.70 mgN/dL	1.09 mgN/dL
Low urine pool	60	21.9 mgN/dL	0.54 mgN/dL	0.52 mgN/dL
High urine pool	60	75.3 mgN/dL	0.85 mgN/dL	2.91 mgN/dL

The recoveries of urea nitrogen standards, which span the claimed linear range of 0 to 150 mgN/dL, are equivalent between the HiChem and BMD BUN Reagents. Regression statistics are shown below.

(HiChem Results) = 0.0 mgN/dL + 1.005 x (BMD Results), r2 = 1.000, Sy.x = 0.6 mgN/dL.

Urea nitrogen recoveries of 190 mixed serum and plasma specimens diluted with 20 parts normal saline compared between the HiChem and BMD reagents using least squares regression, yield the following statistics.

Serum/Plasma Comparison

(HiChem Results) = 0.0 mgN/dL + 1.009 × (BMD Results) r2 = 0.999 . Sy.x = 0.6 mgN/dL. Urine Comparison (HiChem Results) = 0.1 mgN/dL + 1.027 × (BMD Results) r2 = 0.999. Sv.x = 0.7 mgN/dL.

The calibration stability claim of 48 hours is documented through the recovery of serum controls which span from 8 to 132 mgNdL urea nitrogen. In all cases, the observed shifts in recoveries over the calibration period are less than the greater of 2 mgN/dL or 2%.

The HiChem BUN/Urea Reagent, calibrated with the HiChem Chemistry Standard, is shown to be safe and effective and substantially equivalent to the Sigma BUN (Rate) Reagent, procedure no. 67-UV calibrated with Sigma Clucose/Urea Nitrogen Standard, product no. 16-300 and the BMD BUN Reagent, product no. 704092 calibrated with Precical Calibrator Serum and Diluent, product no. 620213.

Wynn Stocking
Manager, Regulatory Affairs.