(137 days)
Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
The Wako L-Type UN test is an in vitro assay for the quantitative determination of urea nitrogen in serum and plasma. The Wako L-Type UN is a method based on enzymatic assay utilizing urease and glutamate dehydrogenase.
The Wako L-Type UN test is an in vitro assay designed for the quantitative determination of urea nitrogen in serum and plasma. The provided document is a 510(k) summary demonstrating its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance (Wako L-Type UN) |
|---|---|---|
| Accuracy / Correlation | Substantial equivalency to predicate device. Implied correlation coefficient and regression equation demonstrating strong agreement. | Correlation coefficient of [Value Missing]; Regression equation of y = x + [Values Missing] when compared against the predicate assay. |
| Precision / Reproducibility | Acceptable values on a day-to-day basis. | "Precision studies indicate acceptable values can be obtained on a day to day basis." (Specific quantitative values are not provided). |
| Analytical Sensitivity (Minimum Detectable Level) | A specified minimum detectable level. | 0.6 mg/dL |
Note: The exact numerical values for the correlation coefficient and the regression equation are missing from the provided text in the section: "In comparison studies against the predicate assay, a correlation coefficient of and a regression equation of y = x + was obtained."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "comparison studies" but does not provide the number of samples used in these studies.
- Data Provenance: Not explicitly stated. Given that Wako Diagnostics is located in Richmond, VA, U.S.A., and the FDA approval process, it is highly likely that the comparison studies, particularly for clinical samples, were conducted in the U.S. The studies are by nature retrospective as they compare results of the new device against an existing predicate device using collected samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is an in vitro diagnostic (IVD) assay for a quantitative biochemical marker (urea nitrogen). The "ground truth" for such assays is typically established by certified reference methods or established predicate devices, not by expert interpretation of images or clinical cases. The comparison is against another analytical method.
4. Adjudication Method for the Test Set
Not applicable. As described above, the comparison is between analytical methods, not subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is an in vitro diagnostic device, not an imaging device or a diagnostic aid that involves human readers interpreting cases.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance
Yes, the study describes two types of standalone performance:
- Comparison Study: This study directly compares the Wako L-Type UN test (algorithm/method only) against a predicate assay (another algorithm/method only) to demonstrate substantial equivalence. This is a standalone comparison of device performance.
- Precision Study: This study assesses the consistency of the Wako L-Type UN test's results over time, which is also a standalone performance characteristic of the device itself.
- Minimum Detectable Level: This is an intrinsic standalone performance characteristic of the assay.
7. Type of Ground Truth Used
The "ground truth" for the test set was the results obtained from the legally marketed predicate device. The study aims to show substantial equivalence, meaning the new device provides results that are comparable and consistent with an already accepted method for measuring urea nitrogen.
8. Sample Size for the Training Set
Not applicable. This is an in vitro diagnostic assay and generally does not involve a "training set" in the same way machine learning algorithms do. The development of such assays involves method optimization and validation, but the concept of a distinct training set for an algorithm is not directly relevant here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention or implication of a distinct "training set" for an algorithm in this context. The development process would rely on established biochemical principles and analytical chemistry methodologies.
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Image /page/0/Picture/1 description: The image shows a handwritten sequence of characters. The sequence appears to be 'KG93925'. The characters are written in black ink on a white background. The handwriting is somewhat stylized, with some characters slightly distorted.
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Boad Bichmond VA 23237 U.S.A Telephone (804) 271-7677 Telex 293208 WAKO UR(RCA) Facsimile (804) 271-7791
510(K) Summary of Safety and Effectiveness
The Wako L-Type UN test is an in vitro assay for the quantitative determination of urea nitrogen in serum and plasma.
Summary:
In humans, urea is the major nitrogen-containing metabolic product of protein catabolism. The determination of serum urea nitrogen is one of the most widely used tests for the evaluation of kidney function. The test is frequently requested along with the serum creatinine test since simultaneous determination of these two compounds appears to aid in the differentiate diagnosis of prerenal, renal and postrenal azotemia. The procedures for the quantitation of urea nitrogen employ either a direct determination of the urea or an indirect determination of the ammonia released by the enzymatic action of urease on urea.
The Wako L-Type UN is a method based on enzymatic assay utilizing urease and glutamate dehydrogenase. 1,2
Principle:
Urea in a specimen is decomposed to produce ammonia and carbon dioxide catalyzed by urease. In the presence of x-Ketoglutarate and NADH, this ammonia causes the oxidation of an equal amount of NADH to NAD in a reaction catalyzed by glutamate dehydrogenase (GLDH). The decrease in absorbance of NADH at 340nm is directly proportional to the amount of urea in the sample.
The safety and effectiveness of the Wako L-Type UN test is demonstrated by its substantial equivalency to product. Both test systems are used to measure urea in serum. In comparison studies against the predicate assay, a correlation coefficient of and a regression equation of y = x + was obtained. Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is 0.6 mg/dL.
References:
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Burtis, C.A. and Ashwood, E.R., Ed.: Tietz Textbook of Clinical Chemistry, 20d Ed., Saunders, Philadelphia, 1994.
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Kaltwasser, H. and Schlegel, H.G.: Anal. Biochem., 16.132-138 (1966)
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DG Klinische Chemie Mitteilungen 26 (1995) Heft 5.
Tonya Mallory, Sr. Mahager Wako Diagnostics September 22, 1999 1600 Bellwood Road Richmond, VA 23237
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 2000
Ms. Tonya Mallory Senior Manager, Diagnostics Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, Virginia 23237
Re: K993925 Trade Name: Wako L-Type Urea N Regulatory Class: II Product Code: CDQ Dated: February 15, 2000 Received: February 18, 2000
Dear Ms. Mallory:
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 legally marketed predicate 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 general 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 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 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 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 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" (21CFR 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/dsma/dsmamain.html".
Sincerely vours.
Steven Toutman
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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| Labels | Values |
|---|---|
| 510(k) Number (if known): | K993925 |
| Device Name: | Wako L-Type Urea N |
Indications For Use:
Measurements obfained by this device
are used in the diagnosis and treatment
of certain renal and metabolic diseases.
Heal Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
Division of Clinical Laboratory Devices વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપા 510(k) Number.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_b (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.