K Number

Device Name

CARESIDE BUN

Manufacturer

EXIGENT DIAGNOSTICS, INC.

Date Cleared

1998-02-05

(30 days)

Product Code

CDQ 75C

Regulation Number

862.1770

Intended Use

The CareSide™ BUN cartridge is intended for in vitro diagnostic use in conjunction will the Exigent Diagnostics CareSidc™ Analyzer to quantitatively measure urea nitrogen from whole blood, plasma or serum by laboratory professionals. When used in conjunction with the Exigent Diagnostics CareSideTM Creatinine test cartridge on the Exigent Diagnostics CareSide™ Analyzer, the BUN product may be used to calculate a BUN to creatinine ratio. The CareSide™ BUN test aids in the diagnosis and treatment of various renal and metabolic diseases. This product is indicated for use with patients with various renal and metabolic diseases.

Device Description

CareSide™ BUN cartridges are used with the Exigent Diagnostics CareSide™ Analyzer to measure BUN concentration in whole blood, plasma or scrum specimens. The CareSide™ BUN cartidge, a single use disposable in viro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of BUN concentration. The film cartridge (patcht pending) contains all reagents necessary to measure Concentration. "The min and in conjunction with the CareSide™ Creatinine cartridge on the CareSide™ Analyzer, the analyzer calculates a BUN to creatinine ratio. Each Exigent Diagnostics CareSide™ BUN cartridge consists of a BUN-specific multi-Jayer reagent film mounted in a plastic base with a hinged lid. The user introduces the whole blood, serum, or plasma specimen into the cartridge sample deposition well, closes the lid and inserts the cartridge into the Exigent Diagnostics CareSide™ Analyzer. Once loaded, the CareSide™ analyzer scans the carridge barcode, brings the cartidge and the contained speciment to 37℃, and spins the cartidge to move the sample from the sample deposition well into the cartridge channels and chambers. As the cartridge continues to spin, the blood culls are separated from the plasmalscrum and the cells accumulate in the separation well. Ten microliters of plasma (or serum, as applicable) remain in the metering passage. Any excess sample flows into an overflow well, The ten microliters of plasma (or serum, as applicable) is automatically dispensed onto the multi-layer reagent film. The spreading layer distributes the sample evenly on the film and filters large molecular weight components such as protein and dye fragments hefore the specimen enters the reaction layer. Urea then reacts with water in a urcasccatalyzed reaction to produce carbon dioxide and ammonia gas in the alkaline unvironment. The arnmonia gas permeates the porous gas permeation layer to reach the detection layer where it then reacts non-cazymatically with the yellow dye, hromocresol green, to form a green dye. Test Reaction Sequence: Urea + H2O - "Pease > 2NH3 + CO2 Bromocresol green (yellow) + NH3-> Green dye As the cartridges spin, photodiodes measure reflectance of light emitted by wavelengthspecific light cmitting diodes (LEDs) at a lixed time. The analyzer uses the reflectance measurements and the lot-specific standard curve to calculate BUN concontration.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K912844/A

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a chemical reaction and optical measurement process with calculations based on a standard curve, not AI/ML. There are no mentions of AI, ML, or related concepts.

Therapeutic

No.

The device is an in vitro diagnostic (IVD) test cartridge and analyzer for measuring urea nitrogen, which aids in the diagnosis and treatment of renal and metabolic diseases. It does not exert any direct therapeutic effect on the patient.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "The CareSide™ BUN cartridge is intended for in vitro diagnostic use..." and "The CareSide™ BUN test aids in the diagnosis and treatment of various renal and metabolic diseases." This language directly identifies the device's function as diagnostic.

SaMD (Software as a Medical Device)

The device description clearly outlines a physical cartridge and an analyzer, both of which are hardware components. The software is part of the analyzer's function in calculating the BUN concentration and ratio, but it is not the sole component of the medical device.

IVD (In Vitro Diagnostic)

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 CareSide™ BUN cartridge is intended for "in vitro diagnostic use".
Device Description: The "Device Description" also refers to the cartridge as a "single use disposable in vitro diagnostic test cartridge".
Function: The device is designed to quantitatively measure urea nitrogen from biological specimens (whole blood, plasma, or serum) to aid in the diagnosis and treatment of diseases. This is a core function of an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This product is indicated for use with patients with various renal and metabolic diseases.

Product codes (comma separated list FDA assigned to the subject device)

75CDN, CDQ

Device Description

Each Exigent Diagnostics CareSide™ BUN cartridge consists of a BUN-specific multi-Jayer reagent film mounted in a plastic base with a hinged lid. The user introduces the whole blood, serum, or plasma specimen into the cartridge sample deposition well, closes the lid and inserts the cartridge into the Exigent Diagnostics CareSide™ Analyzer.

Once loaded, the CareSide™ analyzer scans the carridge barcode, brings the cartidge and the contained speciment to 37℃, and spins the cartidge to move the sample from the sample deposition well into the cartridge channels and chambers. As the cartridge continues to spin, the blood culls are separated from the plasmalscrum and the cells accumulate in the separation well. Ten microliters of plasma (or serum, as applicable) remain in the metering passage. Any excess sample flows into an overflow well,

The ten microliters of plasma (or serum, as applicable) is automatically dispensed onto the multi-layer reagent film. The spreading layer distributes the sample evenly on the film and filters large molecular weight components such as protein and dye fragments hefore the specimen enters the reaction layer. Urea then reacts with water in a urcasccatalyzed reaction to produce carbon dioxide and ammonia gas in the alkaline unvironment. The arnmonia gas permeates the porous gas permeation layer to reach the detection layer where it then reacts non-cazymatically with the yellow dye, hromocresol green, to form a green dye.

Test Reaction Sequence:

Urea + H2O - "Pease > 2NH3 + CO2

Bromocresol green (yellow) + NH3-> Green dye

As the cartridges spin, photodiodes measure reflectance of light emitted by wavelengthspecific light cmitting diodes (LEDs) at a lixed time. The analyzer uses the reflectance measurements and the lot-specific standard curve to calculate BUN concontration.

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

laboratory professionals

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K912844/A

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

PHONE NO. : 3103386789

98005

FEB - 5 1998

Exigent Diagnostics, Inc. Page 13

CarcSide™ Urea Nitrogen (BUN) Premarket Notification K980057 revised on January 28, 1998

CareSide™ Urea Nitrogen (BUN) V. 510(k) Summary: Safety and Effectiveness

Applicant Information I.

Applicant Name A.

Applicant/Manufacturer Address B.
Telephone Number C.
D. Contact Person
FAX Number E.
e-Mail Address F.
Date 510(k) Summary prepared G.

Device Information II.

Device Name (Trade) A.
Device Name (Classification) B.
Device Classification C.

Exigent Diagnostics, Inc. 6100 Bristol Parkway Culver City, CA 90230 310-338-6767 Kenneth B. Asarch, Pharm.D., Ph.D. 310-338-6789 asarchk@worldnet.att.net January 28, 1998

CareSide™ Urea Nitrogen (BUN) BUN icst system Clinical chemistry panel BUN test system Regulation Number: 21 CFR 862.1770 Regulatory Class II Product Code: 75CDN Tier I None applicable
D. Device Tier
E. Special controls and performance standards

Substantial Equivalence Claim III.

General equivalency claim A..

The ability to monitor analyte-specific blochemical reactions in dry film and other formats is widely recognized and has gained widespread acceptance for use in chemistry assays.

BUN in vitro diagnostic products, in both dry film and other formats, are already on the U.S. market, including BUN products which utilize urease with an ammonia indicator dye.

B. Specific couivalency claim

This CareSide BUN test is substantially equivalent in principle, intended use, and clinical performance to the currently marketed Vitros slides for the quantitative measurement of BUN on the Vitros DT 60 II.

Name of Predicate Device:

Johnson and Johnson's Vitros BUN Slides (formerly Pastman Kodak, Inc.) and Johnson and Johnson's Vitros DT 60 (formerly Eastman Kodak's DT 60 II),

K912844/A Predicate Device 510K number: 75CDN (urease, urea) Product Codc:

Exigent Diagnostics, Inc. Page 13a

IV. Device Description

Explanation of Device Function A.

Test Reaction Sequence:

Urea + H2O - "Pease > 2NH3 + CO2

Bromocresol green (yellow) + NH3-> Green dye

B. Test Summary

Urea is the principal waste product of protein catabolism. Urea is synthesized in the liver from ammonia which is produced as a result of deamination of amino acids. Normally, urca nitrogen in the blood comprises only ahout 45% of protein nitrogen. Urea nitrogen determinations are important in evaluating the function of the kidneys and the liver. Increases in urea nitrogen lovels may be due to prerenal causes (cardiac decompensation, water depletion due to increased intake or excessive loss, or increased catabolism), or renal causes (acute glomerulonephritis, chronic nophritis, polycystic kidney). Increases in urea nitrogen are also seen in metallic poisonia, Addison's disease, perionitis, and surgical shock. Decreases in blood urea nitrogen are seen with nephrosis, acure liver destruction, amyloidosis and pregnancy.

Exigent Diagnostics, Inc. Page 13b

Intended Use V.

Intended Use A.

Indications for Use B.

This product is indicated for use with patients with various renal and metabolic diseases.

VI. Technological Characteristics

Similaritics A.

	CareSide™ BUN	Vitros BUN DT Slides
Intended Use	Primarily to aid in the diagnosis and treatment of certain renal and metabolic diseases.	Same
Indications	For in vitro diagnostic use.
For professional use only.	For in vitro diagnostic use.
Measurement	Quantitative	Same
Reportable range	5 to 140mg/dL	1 to 100mg/dL
Method Principle	Dry film based urease conversion to ammonia and reaction with ammonia indicating dye. Chromogen quantitated by reflectance measurement after fixed time.	Same
Specimen dilution	Not required	Same
Materials Source	Urease: ( Canavalia ensiformis )
Indicator: Bromocresol green (synthetic)	Urease: (Jack bean)
Indicator: N-propyl-4-(2,6-dinitro-4-chlorobenzyl)-quinolinionethane sulfonate (synthetic)
Detector	Reflectance (615 nm)	Reflectance (660 nm)
Test time	Approximately 4 minute warm-up (on-board) plus 6 minute test time.	15 minutes slide warm-up (off-line) plus 5 minutes test time.
Reference Method	Urease conversion to ammonia.
Glutamic dehydrogenase linked NADH oxidation of ammonia.	Same
Sample Type	Serum, plasma, whole blood (wb) [wb applied sample, plasma test sample]	serum, plasma
Specimen volume	10 μl test volume
(85 ± 15 μl applied volume)	10 μl
Calibration	Calibration information bar-coded on each cartridge. Calibration information may change with each lot.	Run Vitros DT II calibrators whenever a new slide lot is used or when necessary.
Quality Control	2 levels	Same
Reporting Units	mg/dL or mmol/L	Same

Exigent Diagnostics, Inc. Page 13c

CareSide™ Urea Nitrogen (BUN) Premarket Notification K980057 revised on January 28, 1998

B. Differences

	CareSide™ BUN	Vitros BUN DT Slides
Direct blood
specimen	Yes, whole blood	No, requires separation of
whole blood prior to sample
application
Accurate
pipetting	Not required	Required
Reagent pre-
warming	Not required	Required

Comparative Performance Characteristics C.

	CareSide™ BUN	Vitros BUN DT Slides
Detection limit	5 mg/dL	1 mg/dL
Reportable range	5 to 140 mg/dL	1 to 100 mg/dL
Accuracy	Mean recovery 100%	Not provided
Precision	Total CV, 26 mg/dL, 3.3%	Total CV, 27 mg/dL, 3.3%
Method
comparison	CareSide™ = 1.00 (Vitros BUN DT) - 3.0, r=0.99
Linearity	Mean deviation approx -6%,
r>0.99	Not provided
Interference	No significant interference observed at tested concentration of interferent:
Ascorbic Acid, 10 mg/dL
Bilirubin, 20 mg/dL
Hemoglobin, 500 mg/dL
Triglycerides 3000 mg/dL	Not provided
Specimen Types
& Anticoagulants	No clinically significant difference between
heparinized whole blood, serum, heparin plasma, and EDTA plasma.	No clinically significant difference between serum and heparin plasma. Whole blood is unsuitable.
Expected Values	6 to 16 mg/dL
(combined male and female)
Central 95% interval	9 to 20 mg/dL (male)
7 to 17 mg/dL (female)
Central 95% interval

D. Conclusion

The nonclinical and clinical data provided demonstrate that the CareSide™ BUN product is as safe, effective, and performs as well as or better than the legally marketed predicate device.

Kenneth B. Asarch, Ph.D.

Exigent Diagnostics Inc. 6100 Bristol Parkway

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings outstretched.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB - 5 1998 VP Quality Systems and Regulatory Affairs

Culver City, California 90230 K980057 Re : CareSide™ BUN Requlatory Class: II

Product Code: CDQ Dated: December 30, 1997 Received: January 6, 1998

Dear Dr. Asarch:

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 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 The general controls provisions of provisions of the Act. 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and-that, through periodic GMP 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 Reqister. 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.

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/dsmamain.html".

Sincerely yours,
Steven Gutman

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

Page / of /

510(k) Number (if known): K980057

Device Name:_

VII. Indications for Use

510(k) Number: Device Name: Indications for use:

To be assigned CareSide™ BUN For in vitro diagnostic use with Exigent Diagnostics CareSide™ Analyzer to measure BUN in whole blood, plasma or serum specimens by professionals to aid in the diagnosis and treatment of various renal and metabolic diseases.

(Please do not write below this lìne-continue on another page if NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ V (Per 21 CFR 801.109)

OR	Over-The-Counter Use
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(Optional Format 1-2-96)
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(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number	980057
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