Cleared Traditional

K951848 - AIA-PACK CPR ASSAY

K951848 is an FDA 510(k) clearance for AIA-PACK CPR ASSAY, manufactured by Tosoh Medics, Inc.. The device is a Class 1 Chemistry device with product code JKD cleared through the Traditional 510(k) pathway after a 298-day FDA review.

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

FDA 510(k) Submission Details - K951848

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
210d slower than avg
Panel avg: 88d · This submission: 298d
Pathway characteristics
Predicate-based equivalence.

JKD Device Classification - Class 1, General Controls

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.

Regulatory Peers - JKD Radioimmunoassay, C-peptides Of Proinsulin

All 7
Devices cleared under the same product code (JKD) and FDA review panel - the closest regulatory comparables to K951848.
IMMULITE C-PEPTIDE
K943767 · Diagnostic Products Corp. · Mar 1995
DSL C-PEPTIDE RIA (DSL #7000)
K896420 · Diagnostic Systems Laboratories, Inc. · May 1990
DOUBLE ANTIBODY C-PEPTIDE RIA KIT
K854066 · Diagnostic Products Corp. · Nov 1985
C-PEPTIDE RADIOIMMUNOASSAY TEST KIT
K833396 · Serono Diagnostics, Inc. · Apr 1984
HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM.
K820666 · Immuno Nuclear Corp. · Jul 1982
RIA QUANT C-PEPTIDE KIT
K812689 · Mallinckrodt Critical Care · Oct 1981