(53 days)
The Sigma Diagnostics INFINITY™ Uric Acid Reagent is intended for the in vitro quantitative, diagnostic determination of uric acid in human serum or urine on both automated and manual systems.
The Sigma Diagnostics INFINITY™ Uric Acid Reagent is a device intended to measure uric acid in serum. Measurements obtained by the 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.
This reagent is based upon the methods of Trivedi and Kabasakallan with a modified Trinder peroxide assay using 2,4,6-Tribromo-3-hydroxy benzoic acid (TBHB).
The series of reactions involved in the assay system is as follows:
-
Uric Acid is oxidized to allantoin by uricase with the production of H2O2. 1.
Uric Acid + O2 + H2O Uricase > Allantoin + CO2 + H2O2 -
The peroxide reacts with 4-aminoantipyrine (4-AAP) and TBHB in the presence of 2. peroxidase to yield a quinoneimine dye. The resulting change in absorbance at 520 nm (500-550 nm) is proportional to uric acid concentration in the sample.
H2O2 + 4-AAP + TBHB Peroxidase > Quinoneimine + H2O
The Sigma Diagnostics INFINITY™ Uric Acid Reagent (Procedure No. 684) is a device intended for the in vitro quantitative determination of uric acid in human serum or urine. It is explicitly indicated for use in the diagnosis and treatment of numerous renal and metabolic disorders. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed de novo clinical study report with acceptance criteria and performance data. Therefore, many of the requested elements for a detailed study report are not explicitly available in the provided text.
Based on the provided information, here's a breakdown of the available details:
Acceptance Criteria and Reported Device Performance
The 510(k) summary states that the INFINITY™ Uric Acid Reagent is "substantially equivalent to, and is the same product as the TRACE Scientific Uric Acid Reagent kit cleared by the FDA as K971485." This implies that the acceptance criteria for this 510(k) submission were met by demonstrating this substantial equivalence, often through comparison of analytical performance characteristics (e.g., precision, accuracy, linearity, measuring range) to the predicate device. However, the specific quantitative acceptance criteria and the reported performance against these criteria are not detailed in the provided summary.
Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Demonstrated to be equivalent to predicate device K971485 | Claims to be "substantially equivalent to, and is the same product as the TRACE Scientific Uric Acid Reagent kit cleared by the FDA as K971485." Specific quantitative performance data not provided. |
| Accuracy | Not explicitly stated in the provided text | Not explicitly stated in the provided text |
| Precision | Not explicitly stated in the provided text | Not explicitly stated in the provided text |
| Measuring Range | Not explicitly stated in the provided text | Not explicitly stated in the provided text |
| Analytical Specificity | Not explicitly stated in the provided text | Not explicitly stated in the provided text |
Study Details:
As this is a 510(k) summary, it focuses on substantial equivalence rather than a detailed standalone clinical study report. Therefore, specific details about sample sizes, ground truth establishment, or expert involvement for a de novo study are not present. The "study" here refers to the comparisons made to establish substantial equivalence with the predicate device (TRACE Scientific Uric Acid Reagent kit, K971485).
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. This type of information would typically be in a more detailed study report, outlining the samples used for comparison studies against the predicate.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. For a diagnostic reagent, ground truth is typically established by reference methods or established laboratory standards, not by human expert interpretation in the same way it would be for an imaging AI device.
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Adjudication method for the test set:
- Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically for resolving discrepancies in human expert interpretations, which is not relevant for a quantitative chemical reagent.
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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:
- No. This is a chemical reagent, not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, MRMC studies are not relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. A chemical reagent operates as a "standalone" analytical system, producing a quantitative result without human interpretive input beyond sample handling and instrument operation. The substantial equivalence demonstration would have evaluated the performance of the reagent directly.
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The type of ground truth used:
- For a chemical assay, the "ground truth" for demonstrating substantial equivalence typically involves comparison against:
- Reference method/materials: Established analytical methods or certified reference materials with known uric acid concentrations.
- Predicate device results: Direct comparison of results obtained with the new device versus the predicate device on the same set of patient samples.
- The specific method used is not detailed in the provided text, but it would fall into one of these categories.
- For a chemical assay, the "ground truth" for demonstrating substantial equivalence typically involves comparison against:
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The sample size for the training set:
- Not applicable/Not specified. Chemical reagents do not typically have "training sets" in the same sense as machine learning algorithms. Their formulation and optimization are based on chemical principles and experimental validation, not iterative training on data.
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How the ground truth for the training set was established:
- Not applicable/Not specified, as there is no "training set" in the context of a chemical reagent.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
INFINITY™ Uric Acid Reagent, Procedure 684
Sigma Diagnostics INFINITY™ Uric Acid Reagent is intended for the in vitro quantitative, diagnostic determination of uric acid in human serum or urine on both automated and manual systems.
Uric acid is a metabolite of purines, nucleic acids and nucleoproteins. Consequently, abnormal levels may be indicative of a disorder in the metabolism of these substances. Hyperuricaemia may be observed in renal dysfunction, gout, leukemia, polycythaemia, atherosclerosis, diabetes, hypothyroidism, or in some genetic diseases. Decreased levels are present in patients with Wilson's Disease.1-3
This reagent is based upon the methods of Trivedi and Kabasakallan45 with a modified Trinder8 peroxide assay using 2,4,6-Tribromo-3-hydroxy benzoic acid (TBHB).
The series of reactions involved in the assay system is as follows:
-
Uric Acid is oxidized to allantoin by uricase with the production of H2O2. 1.
Uric Acid + O2 + H2O Uricase > Allantoin + CO2 + H2O2 -
The peroxide reacts with 4-aminoantipyrine (4-AAP) and TBHB in the presence of 2. peroxidase to yield a quinoneimine dye. The resulting change in absorbance at 520 nm (500-550 nm) is proportional to uric acid concentration in the sample.
H2O2 + 4-AAP + TBHB Peroxidase > Quinoneimine + H2O
The Sigma Diagnostics INFINITY™ Uric Acid Reagent (Procedure No. 684) is substantially equivalent to, and is the same product as the TRACE Scientific Uric Acid Reagent kit cleared by the FDA as K971485.
References
- Searcy RL: Diagnostic Biochemistry. McGraw-Hill, New York, NY, 1969 】.
- Henry RJ, Common C, Winkelman JW (eds), Clinical Chemistry: Principles and 2. Techniques. Harper & Row, Hagerstown, MD, 1974
-
- Balls ME: Adv Clin Chem 18:213, 1976
- Trivedi R, Berta E, Rebar L: Clin Chem, 22:1223, 1976 4.
- Kabasakallan P, Kalliney S, Wescott A: Clin Chem, 19:522, 1973 న.
- Trinder P: J Clin Pathol, 22:246, 1949 6.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. The logo is black and white.
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
AUG 1 8 1998
William Gilbert, Ph.D. Manager, Scientific Affairs Sigma Diagnostics Inc. 545 South Ewing Avenue St. Louis, Missouri 63103
Re : K982251 INFINITY™ Uric Acid Reagent (Procedure No. 684) Requlatory Class: I Product Code: CDO Dated: June 23, 1998 Received: June 26, 1998
Dear Dr. Gilbert:
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 general controls provisions The general controls provisions of the Act 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. ਕੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 In addition, FDA may publish further announcements action. 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.
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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
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Page_____of __
510(k) Number (if known):
Device Name: INFINITY ™ Uric Acid Reagent ___
Indications For Use:
The Sigma Diagnostics INFINITY™ Uric Acid Reagent is a device intended to measure uric acid in serum. Measurements obtained by the 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of Clinical Laboratory Devices
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§ 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.