(29 days)
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.
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.
This is a 510(k) summary for the IL Test™ Urea Nitrogen device, an in vitro diagnostic test for the quantitative determination of urea and urea nitrogen in human serum, plasma, or urine. The device primarily relies on a "substantial equivalence" claim to a predicate device (IL Test™ Urea Nitrogen K932467 K943595). Therefore, the acceptance criteria and study design are centered around demonstrating this equivalence.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Method Comparison (Correlation to Predicate Device) | |
| Serum samples: High correlation (r) to predicate | r = 0.997 (for 49 serum samples) |
| Urine samples: High correlation (r) to predicate | r = 1.000 (for 25 urine samples) |
| Precision (Within Run CV) | |
| Serum sample: Low CV at 17 mg/dL | CV = 2.1 % |
| Serum sample: Low CV at 50 mg/dL | CV = 2.2 % |
| Urine sample: Low CV at 912 mg/dL | CV = 2.2 % |
Note: The document implies "high correlation" and "low CV" as the implicit acceptance criteria by presenting specific good performance values relative to a predicate device. Specific numerical thresholds for acceptance were not explicitly stated beyond these reported results.
2. Sample sizes used for the test set and the data provenance
- Test Set for Method Comparison:
- Serum samples: 49
- Urine samples: 25
- Test Set for Precision: The number of runs or individual measurements for precision is not explicitly stated, but it was "accessed over multiple runs." For each precision test, only one sample (a serum sample or a urine sample) was used, and its CV was determined.
- Data Provenance: The document does not specify the country of origin of the data. It does not explicitly state if the data was retrospective or prospective. However, given it's a performance summary for an in vitro diagnostic device, it typically refers to prospectively collected samples in a controlled laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an in vitro diagnostic test measuring a quantitative analyte (urea nitrogen). The "ground truth" for the test set is established by the measurements from the predicate device (for method comparison) and the device itself (for precision, against its own mean). It does not involve expert interpretation of images or clinical judgments that would require multiple experts for ground truth establishment.
4. Adjudication method for the test set
Not applicable, as this is a quantitative analytical device. "Adjudication" typically refers to resolving discrepancies in expert interpretations in qualitative or subjective diagnostic tasks. For method comparison, the "truth" is the result obtained by the predicate device; for precision, it is the statistical deviation from the mean of repeated measurements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is an in vitro diagnostic test for measuring an analyte, not an AI-assisted diagnostic imaging device that involves human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The performance data presented (method comparison and precision) are "standalone" in that they characterize the analytical performance of the device itself (the "algorithm" in a broader sense of the test methodology) without explicit human intervention in the result determination process beyond standard laboratory procedures for running the test. The device provides quantitative results directly.
7. The type of ground truth used
- For Method Comparison: The "ground truth" for comparison was the results obtained from the predicate device (IL Test™ Urea Nitrogen K932467 K943595).
- For Precision: The "ground truth" is the mean concentration of the control sample, established by repeated measurements of the investigated device itself, with acceptance based on the variability (CV) around that mean.
8. The sample size for the training set
Not applicable. This device is a chemical reagent kit used with clinical chemistry systems. It is not an AI/ML device that requires a "training set" in the computational sense. The "training" of the device is inherent in its chemical formulation and calibration, which would be validated during its development.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of this type of in vitro diagnostic device.
{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
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and three human figures are visible within the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
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.
{2}------------------------------------------------
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 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)
Page 1 of 1
§ 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.