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Galectin-3 In Vitro Diagnostic Assay

Page Type
Product Code
Definition
Galectin-3 is indicated for use in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.
Physical State
in vitro diagnostic reagent kit
Technical Method
enzyme linked immunosorbent assay (ELISA)
Target Area
in vitro diagnostic for use with serum and plasma
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
862.1117
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1117 B-type natriuretic peptide test system

§ 862.1117 B-type natriuretic peptide test system.

(a) Identification. The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.

(b) Classification. Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”

[66 FR 12734, Feb. 28, 2001]

Galectin-3 In Vitro Diagnostic Assay

Page Type
Product Code
Definition
Galectin-3 is indicated for use in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure.
Physical State
in vitro diagnostic reagent kit
Technical Method
enzyme linked immunosorbent assay (ELISA)
Target Area
in vitro diagnostic for use with serum and plasma
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
862.1117
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1117 B-type natriuretic peptide test system

§ 862.1117 B-type natriuretic peptide test system.

(a) Identification. The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.

(b) Classification. Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”

[66 FR 12734, Feb. 28, 2001]