Last synced on 2 December 2022 at 11:04 pm

St2 Assay

Page Type
Product Code
Definition
Immunoassay for the in vitro quantitative determination of soluble ST2 protein in human serum and plasma.
Physical State
test reagents
Technical Method
Quantitative sandwich monoclonal ELISA
Target Area
In Vitro Diagnostics
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]

St2 Assay

Page Type
Product Code
Definition
Immunoassay for the in vitro quantitative determination of soluble ST2 protein in human serum and plasma.
Physical State
test reagents
Technical Method
Quantitative sandwich monoclonal ELISA
Target Area
In Vitro Diagnostics
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]