UREA NITROGEN (BUN) LIQUID REAGENT by JAS DIAGNOSTIC, INC.

This document is a 510(k) summary for a diagnostic reagent, not a study report for a medical device with an algorithm or AI. Therefore, most of the requested information regarding acceptance criteria, study design, expert ground truth, and AI-specific details is not directly applicable or available in this type of submission.

However, I can extract the relevant information concerning the device's performance justification from the provided text, focusing on the concept of "substantial equivalence" as applicable to this type of device.

Key takeaway: The submission focuses on demonstrating "substantial equivalence" of the new reagent to legally marketed predicate devices, primarily through correlation studies comparing their performance on human serum samples. This is a common approach for in vitro diagnostic reagents where performance standards are often established by comparison to existing, accepted methods.

Here's an attempt to address the points based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Acceptable correlation/result comparisons with predicate devices on human serum.	"Correlation studies on human serum demonstrated acceptable result comparisons between these methods, which all use similar normal ranges." (Specific metrics like correlation coefficient, bias, or acceptable difference ranges are not provided in this summary).
Similar intended use to predicate devices.	"The JAS Urea Nitrogen (BUN) Liquid Reagent's intended use is identical to predicate Devices."
Acceptable performance on automated chemistry analyzers tested.	"its performance acceptable on the automated chemistry analyzers tested." (Specific analyzer types or performance metrics are not provided in this summary).
Similar normal ranges as predicate devices.	"Correlation studies... which all use similar normal ranges."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The document only states "human serum" was used for correlation studies.
Data Provenance: Not specified (e.g., country of origin). The document implies the data was collected as part of the validation for this specific 510(k) submission.
Retrospective or Prospective: Not specified, but typically, these correlation studies would be prospective or involve freshly collected samples for evaluation.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. For a reagent comparing its performance to predicate reagents, "ground truth" is typically established by the results of the legally marketed predicate device(s) or an established reference method. There is no mention of "experts" in the sense of clinical reviewers establishing ground truth for individual cases. The expertise lies in the analytical method comparison.

4. Adjudication Method for the Test Set

Not Applicable. There is no mention of an adjudication process as would be used for image interpretation or clinical diagnosis. The "adjudication" here is implied by the quantitative comparison of results between the new reagent and predicate reagents.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not Applicable. This is a diagnostic reagent for quantitative measurement, not an AI-assisted device for human interpretation like an imaging algorithm. Therefore, an MRMC study is not relevant to this type of device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. This is a reagent. It performs its function (chemical reaction for quantitative measurement) independently once applied to the sample on an automated analyzer. There is no "algorithm" in the sense of AI or image processing. Its performance is inherently "standalone" in operating on the sample.

7. The Type of Ground Truth Used

For this type of device, the "ground truth" (or reference standard) is implicitly the results obtained from the predicate devices (Roche Diagnostics BUN (Urea Nitrogen) Reagent for the Cobas Mira analyzers and Pointe Scientific Urea Nitrogen (BUN) Reagent). The study aims to show that the new reagent's results align "acceptably" with these established methods.

8. The Sample Size for the Training Set

Not Applicable. In the context of a diagnostic reagent, there is no "training set" in the sense of machine learning. The reagent's formulation and manufacturing process are developed through R&D, not trained on data.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. See point 8.

Summary

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JUL 1 7 2001

K011596

0000000000

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: 305 418-2320 Fax: 305 418-2321 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

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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, (201) 594-4788. Addinonally, for quest.org of (501) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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Page 1 of 1

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

(Please do not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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)

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.