Cleared Traditional

CEDIA DIGOXIN (K970881) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K970881 · Boehringer Mannheim Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
65d
Days
Class 2
Risk

K970881 is an FDA 510(k) clearance for the CEDIA DIGOXIN. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on May 14, 1997 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3320 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boehringer Mannheim Corp. devices

Submission Details

510(k) Number K970881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1997
Decision Date May 14, 1997
Days to Decision 65 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 87d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KXT Enzyme Immunoassay, Digoxin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3320
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - KXT Enzyme Immunoassay, Digoxin

All 43
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K970881.
ELECSYS DIGOXIN
K973112 · Boehringer Mannheim Corp. · Oct 1997
DIGOXIN DG-II FPIA REAGENT SET
K972794 · Sigma Diagnostics, Inc. · Jul 1997
CEDIA DIGOXIN II
K970883 · Boehringer Mannheim Corp. · May 1997
IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2
K963062 · Beckman Instruments, Inc. · Dec 1996
AXSYM DIGOXIN II
K953718 · Abbott Laboratories · Sep 1995
IMX DIGOXIN
K952079 · Abbott Laboratories · Jul 1995