Cleared Traditional

AIA-PACK CPR ASSAY (K951848) - FDA 510(k) Clearance

Class I Chemistry device.

K951848 · Tosoh Medics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
298d
Days
Class 1
Risk

K951848 is an FDA 510(k) clearance for the AIA-PACK CPR ASSAY. Classified as Radioimmunoassay, C-peptides Of Proinsulin (product code JKD), Class I - General Controls.

Submitted by Tosoh Medics, Inc. (Foster City, US). The FDA issued a Cleared decision on February 13, 1996 after a review of 298 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1135 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Tosoh Medics, Inc. devices

Submission Details

510(k) Number K951848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1995
Decision Date February 13, 1996
Days to Decision 298 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
210d slower than avg
Panel avg: 88d · This submission: 298d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JKD Radioimmunoassay, C-peptides Of Proinsulin
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1135
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.