Cleared Traditional

K942455 - LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEM

K942455 is an FDA 510(k) clearance for LIFESCAN SURESTEP BLOOD GLUCOSE MONITOR..., manufactured by Lifescan, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K942455 · Lifescan, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
305d
Days
Class 2
Risk

K942455 is an FDA 510(k) clearance for the LIFESCAN SURESTEP BLOOD GLUCOSE MONITORING SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Lifescan, Inc. (Milpitas, US). The FDA issued a Cleared decision on March 24, 1995 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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. Elevated predicate reliance profile. 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 Lifescan, Inc. devices

FDA 510(k) Submission Details - K942455

510(k) Number K942455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1994
Decision Date March 24, 1995
Days to Decision 305 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
217d slower than avg
Panel avg: 88d · This submission: 305d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 - CGA Glucose Oxidase, Glucose

All 285
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K942455.
GLUCOMETER ELITE M BLOOD GLUCOSE METER
K951537 · Bayer Corp. · Jul 1995
ONE TOUCH II HOSPITAL BLOOD GLUCOSE MONITORING SYSTEM
K950816 · Lifescan, Inc. · Jul 1995
ONE TOUCH PROFILE COMPLETE DIABETES TRACKING SYSTEM
K950727 · Lifescan, Inc. · Jun 1995
SIGMA GLUCOSE REAGENT
K933694 · Sigma Chemical Co. · Nov 1994
DMA GLUCOSE (OXIDASE) PROCEDURE
K943241 · Data Medical Associates, Inc. · Oct 1994
GLUCOFILM TEST STRIPS
K936212 · Heraeus Kulzer, Inc. · May 1994