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Uric Acid Test System For At Home Prescription Use

Page Type
Product Code
Definition
For the quantitative measurement of uric acid in home use settings by patients diagnosed with gout. This device is for prescription use only.
Physical State
Handheld meter
Technical Method
Quantitative enzymatic activity assay
Target Area
Capillary whole blood, in vitro diagnostic use.
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 1
Regulation Number
862.1775
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 862.1775 Uric acid test system

§ 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.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019; 85 FR 18445, Apr. 2, 2020]

Uric Acid Test System For At Home Prescription Use

Page Type
Product Code
Definition
For the quantitative measurement of uric acid in home use settings by patients diagnosed with gout. This device is for prescription use only.
Physical State
Handheld meter
Technical Method
Quantitative enzymatic activity assay
Target Area
Capillary whole blood, in vitro diagnostic use.
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 1
Regulation Number
862.1775
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 862.1775 Uric acid test system

§ 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.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71797, Dec. 30, 2019; 85 FR 18445, Apr. 2, 2020]