(29 days)
Not Found
No
The device description and performance studies focus on standard in vitro diagnostic chemistry methods (enzyme-coupled urease/GLDH) and statistical metrics (correlation, CV), with no mention of AI or ML.
No.
The device is an in vitro diagnostic test for the quantitative determination of urea and urea nitrogen, which helps diagnose conditions but does not treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states that "IL Test™ Urea Nitrogen is an in vitro diagnostic test."
No
The device is an in vitro diagnostic test kit, which is a chemical reagent-based system used with specific hardware (clinical chemistry systems), not a standalone software application.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in both the "Intended Use / Indications for Use" and "Device Description" sections that the IL Test™ Urea Nitrogen is an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
IL Test™ Urea Nitrogen is an in vitro diagnostic test for use with Instrumentation Laboratory's line of clinical chemistry systems in the quantitative determination of urea and urea nitrogen in human serum, plasma or urine by enzyme-coupled urease/GLDH methodology. Increases in serum urea nitrogen (urea) can be a result of kidney dysfunction or urinary tract obstruction.
Product codes (comma separated list FDA assigned to the subject device)
CDO
Device Description
IL Test™ Urea Nitrogen is an in vitro diagnostic test for use with Instrumentation Laboratory's line of clinical chemistry systems in the quantitative determination of urea and urea nitrogen in human serum, plasma or urine by enzyme-coupled urease/GLDH methodology.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
In a method comparison study evaluating 49 serum samples, the correlation (r) of the new IL Test™ Urea Nitrogen to the predicate IL Test™ Nitrogen was 0.997. In a separate study evaluating 25 urine samples, the correlation (r) of the new IL Test™ Urea Nitrogen to the predicate IL Test™ Urea Nitrogen was 1.000.
Within run precision for a serum sample accessed over multiple runs gave a CV of 2.1 % at a mean of 17 mg/dL and 2.2 % at a mean of 50 mg/dL. Within run precision for a urine sample accessed over multiple runs gave a CV of 2.2 % at a mean of 912 mg/dL.
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.
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
§ 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
SECTION 3
IL Test™ Urea Nitrogen - 510(k) SUMMARY (Summary of Safety and Effectiveness)
Submitted by:
Carol Marble Regulatory Affairs Engineer Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02173 Phone: (617) 861-4467 (617) 861-4464 Fax:
Contact Persons:
Carol Marble Phone: (617) 861-4467 Alternate: Betty Lane Phone: (617) 861-4182
Summary Prepared:
November 17, 1997
Name of the device:
IL Test™ Urea Nitrogen
Classification name(s):
| 862.1770 | Urea Nitrogen test systems | Class II |
|---|---|---|
| 75CDN | Urease, Photometric, Urea Nitrogen |
Identification of predicate device(s):
IL Test™ Urea Nitrogen K932467 K943595 - Serum and Urine Claims Added
Description of the device/intended use(s):
IL Test™ Urea Nitrogen is an in vitro diagnostic test for use with Instrumentation Laboratory's line of clinical chemistry systems in the quantitative determination of urea and urea nitrogen in human serum, plasma or urine by enzyme-coupled urease/GLDH methodology. Increases in serum urea nitrogen (urea) can be a result of kidney dysfunction or urinary tract obstruction.
Statement of how the Technological Characteristics of the Device compare to the Predicate device:
The new IL Test™ Urea Nitrogen uses the same methodology as the predicate IL Test™ Urea Nitrogen and is substantially equivalent in performance, intended use, and safety and effectiveness.
Summary of Performance Data:
In a method comparison study evaluating 49 serum samples, the correlation (r) of the new IL Test™ Urea Nitrogen to the predicate IL Test™ Nitrogen was 0.997. In a separate study evaluating 25 urine samples, the correlation (r) of the new IL Test™ Urea Nitrogen to the predicate IL Test™ Urea Nitrogen was 1.000.
Within run precision for a serum sample accessed over multiple runs gave a CV of 2.1 % at a mean of 17 mg/dL and 2.2 % at a mean of 50 mg/dL. Within run precision for a urine sample accessed over multiple runs gave a CV of 2.2 % at a mean of 912 mg/dL.
DEC I 7 1997
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 17 1997
Carol Marble Requlatory Affairs Engineer Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, Massachusetts 02173-3190
Re: K974337 IL Test™ Urea Nitrogen Regulatory Class: II Product Code: CDO Dated: November 17, 1997 Received: November 18, 1997
Dear Ms. Marble:
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 qeneral controls provisions of the Act. The general controls provisions of 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 Requlations, 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 comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 requlations.
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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 Litman
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
3
Indications for Use Statement
510(k) Number (if known): K974337
Device Name: IL Test™ Urea Nitrogen
Indications for Use:
IL Test™ Urea Nitrogen is an in vitro diagnostic test for use with Instrumentation Laboratory's line of clinical chemistry systems in the quantitative determination of urea and urea nitrogen in human serum, plasma or urine by enzyme-coupled urease/GLDH methodology. Increases in serum urea nitrogen (urea) can be a result of kidney dysfunction or urinary tract obstruction'.
'Friedman, R. et al., Effects of Diseases on Clinical Laboratory Tests, Clin. Chem., 26: (4), 1980
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| | (Division Sign-Off)
Division of Clinical Laboratory Devices |
|---------------|----------------------------------------------------------------|
| 510(k) Number | K974334 |
| Prescription Use
| (Per 21 CFR 801.019) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
Section 2
IL Test™ Urea Nitrogen 510(k)
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