(54 days)
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No
The summary describes a chemical reagent for quantitative determination of urea nitrogen, which is a standard laboratory test and does not involve AI/ML. There are no mentions of AI, ML, image processing, or any other indicators of AI/ML technology.
No
It is a diagnostic device used for in vitro quantitative determination of urea nitrogen, which aids in the diagnosis and treatment of diseases, rather than directly providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Urea Nitrogen measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases," indicating its role in diagnosis.
No
The device description clearly states it is a "Reagent," which is a chemical substance used in a laboratory test, not a software program.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Intended for the In Vitro, quantitative determination of urea nitrogen (BUN) in human serum". "In Vitro" means outside of the living body, and "determination" refers to measuring a substance.
- Device Description: The device description reiterates that it's for "in vitro quantitative determination of urea nitrogen in human serum".
- Purpose: The intended use also states that the measurements are "used in the diagnosis and treatment of certain renal and metabolic diseases". This indicates a medical purpose related to diagnosis and treatment, which is a key characteristic of IVDs.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease.
N/A
Intended Use / 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.
Product codes
CDQ
Device Description
This Reagent is intended for the in vitro quantitative determination of urea nitrogen in human serum.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Correlation studies on human serum demonstrated acceptable result comparisons between these methods, which all use similar normal ranges.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
JUL 1 7 2001
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.
1
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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Page 2
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
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)