(137 days)
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No
The description details a standard enzymatic assay for urea nitrogen, with no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
The device is an in vitro diagnostic (IVD) assay used for quantitative determination of a substance, not a device directly used in therapy. While its measurements aid in diagnosis and treatment decisions, the device itself does not directly treat the condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases."
No
The device description clearly states it is an "in vitro assay" and a "method based on enzymatic assay utilizing urease and glutamate dehydrogenase," which are descriptions of a chemical or biological test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the measurements are "used in the diagnosis and treatment of certain renal and metabolic diseases." This is a key characteristic of an IVD, as it's used to provide information for medical diagnosis.
- Device Description: The description clearly states it's an "in vitro assay for the quantitative determination of urea nitrogen in serum and plasma." "In vitro" means "in glass" or "outside the body," which is the defining characteristic of an IVD. It analyzes samples taken from the body (serum and plasma).
N/A
Intended Use / Indications for Use
Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.
Product codes (comma separated list FDA assigned to the subject device)
CDQ
Device Description
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. Urea in a specimen is decomposed to produce ammonia and carbon dioxide catalyzed by urease. In the presence of $\alpha$-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.
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)
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
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.
Image /page/0/Picture/2 description: The image shows a logo with the word "Wako" in white letters against a black background. The word is slightly tilted to the right. The background is not a perfect rectangle, as the left side has a rough, uneven edge.
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
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked one behind the other.
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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of I Page
| 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)