(27 days)
Intended for measure uric acid in serum, plasma and are used in the obtain and urine. Measurements and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
The Wako L-Type UA F Test is an in vivo assay for the quantitative determination of uric acid in serum and plasma. The Wako L-Type UA F is a method utilizing uricase, N-ethyl-N-(2-hydroxy-3sulfopropyl)-3,5-dimethoxy-4-fluoroaniline (F-DAOS) and 4-aminoantipyrine.
Here's a breakdown of the acceptance criteria and study information for the Wako L-Type UA F Test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Method Comparison | Correlation Coefficient (vs. predicate) | High correlation (e.g., >0.9) | 0.970 |
| Regression Equation (vs. predicate) | Close to y = x | y = 1.028x - 0.34 | |
| Precision | Reproducibility/Consistency | Acceptable values | Acceptable values can be obtained on a day-to-day basis |
| Sensitivity | Minimum Detectable Level (LOD) | Undefined | 0.2 mg/dL |
Note: The document explicitly states "The safety and effectiveness of the Wako L-Type UA F Test is demonstrated by its substantial equivalency to the Wako UA 30R Uric Acid product." Therefore, the predicate device's performance serves as the de facto acceptance criteria for comparing method performance. The acceptance criteria for precision and minimum detectable level are not explicitly stated as numerical targets in this summary, but rather implied by the statement of "acceptable values" and the reporting of the LOD.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated for the method comparison study. The document only mentions "In comparison studies against the predicate assay."
- Data Provenance: Not specified. It does not mention the country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. This device is an in vitro diagnostic (IVD) assay for quantitative measurement of a biomarker. The ground truth would typically be established by the reference method (the predicate device in this case), not by expert human graders.
4. Adjudication Method for the Test Set:
- Not applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. This is an IVD device measuring a biochemical parameter, not an imaging or diagnostic device that involves human reader interpretation. Therefore, an MRMC study is not relevant to this type of device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, effectively. The "comparison studies against the predicate assay" represent a standalone performance evaluation of the Wako L-Type UA F Test. It measures the device's output (uric acid concentration) and compares it directly to the output of the predicate device.
7. The Type of Ground Truth Used:
- Predicate device's measurements. The ground truth for evaluating the Wako L-Type UA F Test's performance in the comparison study was the results obtained from the "Wako UA 30R Uric Acid product." This is a common approach for establishing substantial equivalence for new IVD assays.
8. The Sample Size for the Training Set:
- Not applicable / Not stated. For an in vitro diagnostic assay like this, there isn't typically a "training set" in the sense of machine learning. The development of the assay's reagents and methodology would involve internal R&D, but the document does not describe a separate "training set" with associated ground truth as one would for an AI/ML diagnostic.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As noted above, the concept of a training set for an AI/ML algorithm doesn't directly apply here. The fundamental principles of the assay rely on established biochemical reactions (enzymatic oxidation, colorimetric measurement) rather than a trained algorithm. The "ground truth" for developing such a test is the accurate biochemical quantification of uric acid.
{0}------------------------------------------------
Wako Chemicals USA, Inc. 1600 Bellwood Road, Richmond, VA 23237 U.S.A
510(K) Summary of Safety and Effectiveness
The Wako L-Type UA F Test is an in vivo assay for the quantitative determination of uric acid in serum and plasma.
Summary:
Wako
In human, uric acid is the major product of the catabolism of the purine necleosides. Purines are from catabolism of dietary nucleic acid and degradation of endogenous nucleic acid. Measurement of serum uric acid is largely of use in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions and of patients received cytotoxic drugs. There are several methods used for the measurement of uric acid concentration.
The Wako L-Type UA F is a method utilizing uricase, N-ethyl-N-(2-hydroxy-3sulfopropyl)-3,5-dimethoxy-4-fluoroaniline (F-DAOS) and 4-aminoantipyrine. 1,2
Principle:
Uric acid in a specimen is oxidized in a reaction catalyzed by uricase that produces hydrogen peroxide. In the presence of peroxidase (POD), hydrogen peroxide participates in the oxidative condensation between F-DAOS and 4-aminoantipyrine to form a blue pigment. The amount of uric acid is determined by measuring the absorbance of this pigment.
The safety and effectiveness of the Wako L-Type UA F Test is demonstrated by its substantial equivalency to the Wako UA 30R Uric Acid product. Both test systems are used to measure to measure uric acid in the serum. In comparison studies against the predicate assay, a correlation coefficient of 0.970 and a regression equation of y = 1.028x - 0.34 was obtained. Precision studies indicate acceptable values can be obtained on a day-to-day basis. The minimum detectable level of this method is 0.2 md/dL.
References:
-
Burtis, C.A. and Ashwood, E.R., Ed.: Tietz Textbook of Clinical Chemistry, 2nd Ed., Saunders, Philadelphia, 1994.
-
Kabasakalian, P. Kalliney, S. and Westcott, A .: Clin. Chem., 19, 522-524 (1973).
-
DG Klinische Chemie Mitteilungen 26 (1995) Heft 5.
Luiza Mallmann
Tonya Manory, Sr. Manager Wako Diagnostics September 22, 1999 1600 Bellwood Road Richmond, VA 23237
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a symbol that resembles three stylized human profiles facing to the right, with flowing lines connecting them. The symbol is meant to represent health and human services.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Nov - 9 1999
Ms. Tonya Mallory Senior Manager Wako Diagnostics 1600 Bellwood Road Richmond, Virginia 23237
Re: K993469 Trade Name: Wako L-Type UA F Test Regulatory Class: I Product Code: JHB Dated: September 28, 1999 Received: October 13, 1999
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.
{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/dsma/dsmamain.html".
Sincerely yours,
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
{3}------------------------------------------------
2002
Page of
| Labels | Values |
|---|---|
| 510(k) Number (if known): | K99 3469 |
| Device Name: | Wako L-Type UAE Test |
Indications For Use:
Intended formeasure unic acid in senum, plasma and are used in th obfair ad unne. Measurements and treatment of numerous renal and metabolic leukemia, disorders, induding venal failure, gout, conditions, psoriasis, starvation or other wasting and of patients veceiving cytotoxic drugs.
Jan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993469
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
§ 862.1775 Uric acid test system.
(a)
Identification. A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.(b)
Classification. Class I (general controls). The device, when it is solely intended for use as an acid reduction of ferric ion test, a phosphotungstate reduction test, a gasometric uricase test, an ultraviolet uricase test, or an oxygen rate uricase test, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.