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Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
862.1060
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1060 Delta-aminolevulinic acid test system

§ 862.1060 Delta-aminolevulinic acid test system.

(a) Identification. A delta-aminolevulinic acid test system is a device intended to measure the level of delta-aminolevulinic acid (a precursor of porphyrin) in urine. Delta-aminolevulinic acid measurements are used in the diagnosis and treatment of lead poisoning and certain porphyrias (diseases affecting the liver, gastrointestinal, and nervous systems that are accompanied by increased urinary excretion of various heme compounds including delta-aminolevulinic acid).

(b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]

Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
862.1060
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1060 Delta-aminolevulinic acid test system

§ 862.1060 Delta-aminolevulinic acid test system.

(a) Identification. A delta-aminolevulinic acid test system is a device intended to measure the level of delta-aminolevulinic acid (a precursor of porphyrin) in urine. Delta-aminolevulinic acid measurements are used in the diagnosis and treatment of lead poisoning and certain porphyrias (diseases affecting the liver, gastrointestinal, and nervous systems that are accompanied by increased urinary excretion of various heme compounds including delta-aminolevulinic acid).

(b) Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

[52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000]