Assay, 1,5-Anhydroglucitol (15ag)

NOZ · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.7470

Classification

FDA Product Code: NOZ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 864.7470
Review panel: HE
Medical specialty: Hematology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

The test provides quantitative measurement of 1,5-anhydroglucitol (15AG) in patient's blood. The test is for professional use, and is indicated for the monitoring of glycemic control in people with diabetes.

Market data

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

Source

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