K993469 · Wako Chemicals USA, Inc. · KNK · Nov 9, 1999 · Clinical Chemistry
Device Facts
Record ID
K993469
Device Name
WAKO L-TYPE UA F TEST
Applicant
Wako Chemicals USA, Inc.
Product Code
KNK · Clinical Chemistry
Decision Date
Nov 9, 1999
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.1775
Device Class
Class 1
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.
Device Story
In vitro diagnostic assay for quantitative uric acid measurement in serum, plasma, and urine. Principle: uricase-catalyzed oxidation of uric acid produces hydrogen peroxide; peroxidase-mediated oxidative condensation of F-DAOS and 4-aminoantipyrine forms a blue pigment. Absorbance of pigment measured to determine uric acid concentration. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing and monitoring renal and metabolic conditions, including gout and renal failure, and managing patients on cytotoxic therapy.
Clinical Evidence
Bench testing only. Comparison study against predicate assay yielded a correlation coefficient of 0.970 and regression equation y = 1.028x - 0.34. Precision studies demonstrated acceptable day-to-day performance. Minimum detectable level is 0.2 mg/dL.
Technological Characteristics
Enzymatic colorimetric assay. Reagents: uricase, N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxy-4-fluoroaniline (F-DAOS), and 4-aminoantipyrine. Detection via absorbance measurement of blue pigment. In vitro diagnostic reagent kit.
Indications for Use
Indicated for the quantitative determination of uric acid in serum, plasma, and urine to aid in the diagnosis and treatment of renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation, wasting conditions, and for patients receiving cytotoxic drugs.
Regulatory Classification
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.
Predicate Devices
Wako UA 30R Uric Acid
Submission Summary (Full Text)
{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:
1. Burtis, C.A. and Ashwood, E.R., Ed.: Tietz Textbook of Clinical Chemistry, 2nd Ed., Saunders, Philadelphia, 1994.
2. Kabasakalian, P. Kalliney, S. and Westcott, A .: Clin. Chem., 19, 522-524 (1973).
3. 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
| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|-------------------------|
| 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)
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
