Cleared Traditional

K051376 - ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM

K051376 is the FDA 510(k) clearance for ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM by Roche Diagnostics. It is a Class 1 Chemistry device (product code CHH) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K051376 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
89d
Days
Class 1
Risk

K051376 is an FDA 510(k) clearance for the ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL,.... Classified as Enzymatic Esterase--oxidase, Cholesterol (product code CHH), Class I - General Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on August 23, 2005 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1175 - 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.

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Submission Details

510(k) Number K051376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2005
Decision Date August 23, 2005
Days to Decision 89 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
1d slower than avg
Panel avg: 88d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CHH Enzymatic Esterase--oxidase, Cholesterol
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1175
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 - CHH Enzymatic Esterase--oxidase, Cholesterol

All 121
Devices cleared under the same product code (CHH) and FDA review panel - the closest regulatory comparables to K051376.
Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System
K163406 · ACON Laboratories, Inc. · Jul 2017
Cholesterol
K150654 · Randox Laboratories, Ltd. · Sep 2015
EASYRA CHOLESTEROL REAGENT
K072249 · Medica Corp. · Feb 2008
COBAS INTEGRA CHOLESTEROL GEN. 2
K031824 · Roche Diagnostics Corp. · Jul 2003
SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP
K992803 · Sigma Diagnostics, Inc. · Sep 1999
CHOL
K981652 · Abbott Laboratories · Jun 1998