(13 days)
KNK
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No
The summary describes a chemical reagent kit and an analyzer that performs enzymatic oxidation and a colorimetric reaction. There is no mention of AI, ML, or any computational analysis beyond standard statistical calculations for performance evaluation.
No.
The device is a reagent kit used for the quantitative determination of uric acid, which is an in vitro diagnostic tool, not a therapeutic device.
Yes
Explanation: The "Intended Use / Indications for Use" section states that "Uric acid results may be used for the diagnosis and treatment of numerous renal and metabolic disorders," indicating that the device provides information used for diagnostic purposes.
No
The device is a reagent kit, which is a chemical substance used in a chemical reaction, not a software program. It is intended for use with a specific analyzer hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the kit is for the "quantitative determination of uric acid in serum and plasma." This is a classic example of an in vitro diagnostic test, as it analyzes biological samples (serum and plasma) outside of the body to provide information for diagnosis and treatment.
- Device Description: The description details a "reagent" used to perform a chemical reaction on a sample to determine a specific analyte (uric acid). This is consistent with the nature of IVD reagents.
- Performance Studies: The document includes sections on "Linear Range," "Detection Limit," "Precision," and "Correlation," which are all standard performance characteristics evaluated for IVD devices to demonstrate their analytical accuracy and reliability.
- Predicate Device: The mention of a "Predicate Device" (Roche Uric Acid Plus Reagent) is common in regulatory submissions for IVDs, where a new device is compared to an already approved device.
The core function of the device is to analyze a biological sample in vitro to provide diagnostic information, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Vitalab Uric Acid Reagent Kit is intended for use with the Vitalab Selectra Analyzer as a system for the quantitative determination of uric acid in serum and plasma. Uric acid results may be used for 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.
The Vitalab Uric Acid Reagent Kit is intended for use with the Vitalab Selectra Analyzer as a ystem or the quantituives of symmer I he Vilalab Offic Acid Reagent Kirls internet for with and be used for the diagnosis and treatment of themselves and treatment of them detection of the and in south and plains. "Off and the reals may be niss , starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
Product codes
KNK
Device Description
The Vitalab Uric Acid Reagent is a two-part for use with the Vitalab Selectra Analyzer. This reagent determines uric acid through enzymatic oxidation by uricase linked to a Trinder indicator reaction utilizing N-ethyl-N-(bydroxy-3sulfopropyl)-toluidine (TOOS) and 4-aminoantipyrine.
Mentions image processing
Not Found
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
The linear range of the Vitalab Uric Acid Reagent is from 0.1 to at least 25 mg/dL, as shown by the Usable Range: recovery of linearity standards that span the linear range. Least squares regression statistics, forced through the origin, compare recoveries to standard concentrations.
Detection Limit: Normal saline was assayed thirty times in a single analytical run. The mean and standard deviation of the results are both 0.0 mg/dL. The minimum detection limit, calculated as the mean plus two stadard deviations of the recovery values, is rounded up to 0.1 mg/dL, which is the round-off error of the assay.
Precision is demonstrated by the replicate assay of commercially available control serum. Precision Precision: statistics, calculated analogous to the method described in NCCLS Guideline EP3-T, are shown below.
Sixty serum specimens ranging from 3.6 to 10.2 mg/dL uric acid and 60 heparinized plasma specimens ranging from 2.1 to 10.6 mg/dL uric acid were collected from adult patients and were assayed for unc ranguig the Vitalab Selectra E Analyzer and another commercially available method. Results were compared by Deming regression and the following statistics were obtained.
The 14 day onboard reagent stability and 7 day calibration stability claims are documented through the I ho 1 directively resgues the claimed periods. In all cases, statistical estimates of total imprecision are less than 0.2 mg/dL.
Key Metrics
Linear Range: 0.1 to at least 25 mg/dL
Detection Limit: 0.1 mg/dL
Precision (%CV): Serum 1 (0.7% within run, 1.6% total), Serum 2 (0.7% within run, 1.4% total), Serum 3 (0.6% within run, 1.2% total)
Correlation (Deming regression): Selecta == 0:05 mg/dL + 0:995 x Competitive Reagent, s = 0.08 mg/dL, n = 120
Stability: Total imprecision
§ 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.
0
MAR - 8 2004
Brea. CA 92821 T (714) 672-3553 F (714) 672-3554
Summary of 510(k) Safety and Effectiveness Information Vitalab Uric Acid Reagent
Uric Acid Reagent
Indications for Use:
The Vitalab Uric Acid Reagent Kit is intended for use with the Vitalab Selectra Analyzer as a ystem or the quantituives of symmer I he Vilalab Offic Acid Reagent Kirls internet for with and be used for the diagnosis and treatment of themselves and treatment of them detection of the and in south and plains. "Off and the reals may be niss , starvation or other wasting conditions, and of patients receiving cytotoxic drugs.
✓ prescription use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Carol C Benam
Division Sign-Off
Office of In Vitro Diagnostic Office Evaluation and Safe
510(k) K040167