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Fluorometric Method, 17-Hydroxycorticosteroids

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
862.1385
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1385 17-Hydroxycorticosteroids (17-ketogenic steroids) test system

§ 862.1385 17-Hydroxycorticosteroids (17-ketogenic steroids) test system.

(a) Identification. A 17-hydroxycorticosteroids (17-ketogenic steroids) test system is a device intended to measure corticosteroids that possess a dihydroxyacetone

moiety on the steroid nucleus in urine. Corticosteroids with this chemical configuration include cortisol, cortisone 11-desoxycortisol, desoxycorticosterone, and their tetrahydroderivatives. This group of hormones is synthesized by the adrenal gland. Measurements of 17-hydroxycorticosteroids (17-ketogenic steroids) are used in the diagnosis and treatment of various diseases of the adrenal or pituitary glands and gonadal disorders.

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

[52 FR 16122, May 1, 1987; 52 FR 29468, Aug. 7, 1987, as amended at 65 FR 2306, Jan. 14, 2000]

Fluorometric Method, 17-Hydroxycorticosteroids

Page Type
Product Code
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
862.1385
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1385 17-Hydroxycorticosteroids (17-ketogenic steroids) test system

§ 862.1385 17-Hydroxycorticosteroids (17-ketogenic steroids) test system.

(a) Identification. A 17-hydroxycorticosteroids (17-ketogenic steroids) test system is a device intended to measure corticosteroids that possess a dihydroxyacetone

moiety on the steroid nucleus in urine. Corticosteroids with this chemical configuration include cortisol, cortisone 11-desoxycortisol, desoxycorticosterone, and their tetrahydroderivatives. This group of hormones is synthesized by the adrenal gland. Measurements of 17-hydroxycorticosteroids (17-ketogenic steroids) are used in the diagnosis and treatment of various diseases of the adrenal or pituitary glands and gonadal disorders.

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

[52 FR 16122, May 1, 1987; 52 FR 29468, Aug. 7, 1987, as amended at 65 FR 2306, Jan. 14, 2000]