Tyrosine Phosphatase (Ia-2) Autoantibody Assay

OIF · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5660

Classification

FDA Product Code: OIF
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 866.5660
Review panel: IM
Medical specialty: Immunology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

The device is used for the semi-quantitative determination of autoantibodies against tyrosine phosphatase (IA-2) in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).

Market data

Cleared 510(k) submissions: 3
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown