Cleared Traditional

K936013 - EVATEST STRIP

K936013 is an FDA 510(k) clearance for EVATEST STRIP, manufactured by Boehringer Mannheim Italia Spa. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K936013 · Boehringer Mannheim Italia Spa · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
71d
Days
Class 2
Risk

K936013 is an FDA 510(k) clearance for the EVATEST STRIP. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Boehringer Mannheim Italia Spa (I-20126 Milano, Italy, IT). The FDA issued a Cleared decision on February 25, 1994 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K936013

510(k) Number K936013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1993
Decision Date February 25, 1994
Days to Decision 71 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
17d faster than avg
Panel avg: 88d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCX Device Classification - Class 2, Special Controls

Product Code LCX Kit, Test, Pregnancy, Hcg, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
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 Chemistry devices follow this clearance model.

Regulatory Peers - LCX Kit, Test, Pregnancy, Hcg, Over The Counter

All 213
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K936013.
BODYWISE PREGNANCEY TEST
K941771 · Charlton Assoc. · Jul 1994
PREDICTOR HOME PREGNANCY TEST
K940637 · Organon Teknika Corp. · Jun 1994
ANI BIOCARD(TM) HCG TEST
K933794 · Canadian Bioclinical, Ltd. · May 1994
ADVANCE PREGNANCY TEST MODIFICATION
K934516 · Ortho Pharmaceutical Corp. · Feb 1994
HCG PREGNANCY ONE STEP TEST STRIP
K934830 · Tcpi, Inc. · Dec 1993
HCG MIDSTREAM PREGNANCY TEST
K931997 · Mizuho USA, Inc. · Sep 1993
K936013 · EVATEST STRIP
Download PDF FDA Summary Boehringer Mannheim I…