UREA NITROGEN (BUN) LIQUID REAGENT

K011596 · Jas Diagnostic, Inc. · CDQ · Jul 17, 2001 · Clinical Chemistry

Device Facts

• Record ID: K011596
• Device Name: UREA NITROGEN (BUN) LIQUID REAGENT
• Applicant: Jas Diagnostic, Inc.
• Product Code: CDQ · Clinical Chemistry
• Decision Date: Jul 17, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1770
• Device Class: Class 2

Intended Use

Intended for the In Vitro, quantitative determination of urea nitrogen (BUN) in human serum on automated chemistry analyzers. Urea Nitrogen measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

Device Story

JAS Urea Nitrogen (BUN) Liquid Reagent is an in vitro diagnostic reagent for quantitative determination of urea nitrogen in human serum. Used on automated chemistry analyzers in clinical laboratory settings; operated by laboratory technicians. Reagent reacts with serum samples to produce measurable signals corresponding to urea nitrogen concentration. Results assist clinicians in diagnosis and treatment of renal and metabolic diseases. Benefit includes standardized, automated monitoring of patient urea nitrogen levels.

Clinical Evidence

Bench testing only. Correlation studies performed on human serum demonstrated acceptable result comparisons between the subject device and predicate methods.

Technological Characteristics

Liquid reagent for in vitro quantitative determination of urea nitrogen. Designed for use on automated chemistry analyzers. Class II device (21 CFR 862.1770).

Indications for Use

Indicated for the in vitro quantitative determination of urea nitrogen (BUN) in human serum for patients requiring assessment of renal and metabolic function.

Regulatory Classification

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.

Predicate Devices

• Roche Diagnostics BUN (Urea Nitrogen) Reagent for the Cobas Mira analyzers
• Pointe Scientific Urea Nitrogen (BUN) Reagent

Submission Summary (Full Text)

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## JUL 1 7 2001

K011596

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## JAS DIAGNOSTICS: 510(K) NOTIFICATION

## 510(K) SUMMARY

Submitter

Name: Attn: David Johnston JAS Diagnostics, Inc. 7220 N.W. 58th Street Miami, FL 33166 Phone: [phone] Fax: [phone] Email: D.Johnston(@JASDiagnostics.com

Device Name:

Trade Name: JAS Urea Nitrogen (BUN) Liquid Reagent Common Name: Urea Nitrogen Reagent Classification Name: 21 CFR 862.1770

-Roche Diagnostics BUN (Urea Nitrogen) Reagent for the Cobas Predicate Devices: Mira analyzers -Pointe Scientific Urea Nitrogen (BUN) Reagent (generic)

This Reagent is intended for the in vitro quantitative determination Device Description: of urea nitrogen in human serum.

Intended Use: All devices are intended for the detection of Summary of the urea nitrogen in human serum on automated chemistry analyzers. Similarities to the Results Interpretation: Correlation studies on human serum Predicate Devices: demonstrated acceptable result comparisons between these methods, which all use similar normal ranges.

Discussion and Conclusion:

The JAS Urea Nitrogen (BUN) Liquid Reagent's intended use is identical to predicate Devices and it's performance acceptable on the automated chemistry analyzers tested. The JAS Urea Nitrogen (BUN) Liquid Reagent is therefore substantially equivalent to FDA registered Urea Nitrogen (BUN) Reagents currently in the market.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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JUL 1 7 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Public Health Service

Mr. David Johnston Technical Director JAS Diagnostics, Inc. 7220 NW 58th Street Miami, FL 33166

510(K) Number: K011596 Re: Trade/Device Name: Urea Nitrogen (BUN) Reagent Regulation Number: 862.1770 Regulatory Class: II Product Code: CDQ Dated: April 26, 2001 Received: May 24, 2001

Dear Mr. Johnston:

We have reviewed your Section 510(k) notification of intent to market the device referenced wo nave and we have determined the device is substantially equivalent (for the indications for use above and we nave acterine active marketed predicate devices marketed in interstate commerce stated in the onerobare, to regardent date of the Medical Device Amendments, or to devices that prior to may 20, 1978, accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosmone Act (110). - The general controls provisions of the Act include requirements for annual provisions of the Free. "The Frices, 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 (1 remarket rippt val), it the ' over 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 mspootions, the Food and may result in regulatory action. In addition, FDA may publish comply with ans orner 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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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 notification. The I'DA inding of succion.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 CFF Part 801 and If you desire specific acvice for your as in devices), please contact the Office of Compliance at additionally 809.10 for mi vitto diagnosions on the promotion and advertising of your device, [phone]. Addinonally, for quest.org of [phone]. Also, please note the regulation prease contact the Oriece or Somplanet of premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small information on your responsibilities and unber [phone] or [phone] 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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K011596

510(k) Number (if known): Device Name: ___Urea Nitrogen (BUN)_REAGENT_ Indications for Use:

Intended for the In Vitro, quantitative determination of urea nitrogen (BUN) in human serum on automated chemistry analyzers.

Urea Nitrogen measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

Dan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K011596
aboratory Devices

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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)