Cleared Traditional

K961965 - SURE CHECK PREGNANCY TEST

K961965 is an FDA 510(k) clearance for SURE CHECK PREGNANCY TEST, manufactured by Chembio Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K961965 · Chembio Diagnostic Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
35d
Days
Class 2
Risk

K961965 is an FDA 510(k) clearance for the SURE CHECK PREGNANCY TEST. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Chembio Diagnostic Systems, Inc. (Great Neck,, US). The FDA issued a Cleared decision on June 24, 1996 after a review of 35 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.

View all Chembio Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K961965

510(k) Number K961965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1996
Decision Date June 24, 1996
Days to Decision 35 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
53d faster than avg
Panel avg: 88d · This submission: 35d
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 139
Devices cleared under the same product code (LCX) and FDA review panel - the closest regulatory comparables to K961965.
MIDSTREAM ONESTEP PREGNANCY HOME TEST
K963341 · Syntron Bioresearch, Inc. · Dec 1996
QUICKSTICK ONE STEP PREGNANCY TEST(9010)
K962219 · Phamatech · Jul 1996
BRAND NAME 1-STEP PREGNANCY TEST-MAY BE MARKETED UNDER FIRST RESPONSE, ANSWER, OR OTHER BRAND NAMES
K962183 · Armkel, LLC · Jul 1996
TBD AT-HOME PREGNANCY TEST
K961712 · Armkel, LLC · May 1996
CLEARBLUE EASY
K960316 · Unipath , Ltd. · Apr 1996
BEST PREGNANCY TEST
K953606 · Ameritek, Inc. · Mar 1996