Cleared Traditional

K843428 - BIOFIX

K843428 is an FDA 510(k) clearance for BIOFIX, manufactured by Accra Laboratories, Inc.. The device is a Class 1 Pathology device with product code LDZ cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K843428 · Accra Laboratories, Inc. · Pathology device
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Sep 1984
Decision
23d
Days
Class 1
Risk

K843428 is an FDA 510(k) clearance for the BIOFIX. Classified as Fixative, Alcohol Containing (product code LDZ), Class I - General Controls.

Submitted by Accra Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 27, 1984 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.4010 - the FDA pathology 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 Accra Laboratories, Inc. devices

FDA 510(k) Submission Details - K843428

510(k) Number K843428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1984
Decision Date September 27, 1984
Days to Decision 23 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 77d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

LDZ Device Classification - Class 1, General Controls

Product Code LDZ Fixative, Alcohol Containing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.4010
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 - LDZ Fixative, Alcohol Containing

All 7
Devices cleared under the same product code (LDZ) and FDA review panel - the closest regulatory comparables to K843428.
CYTOJARS PREFILLED WITH CYTOLOGY PRESERVATIVE
K881922 · Surgipath Medical Industries, Inc. · May 1988
ATS PVA FIXATIVE SOLUTION
K881698 · Alpha-Tec Systems, Inc. · May 1988
SACCOMANNO SPECIMAN SOLUTION
K862725 · Mill-Rose Laboratory · Aug 1986
WRIGHT STAIN FIXATIVE
K842913 · E K Ind., Inc. · Sep 1984
PVA FIXATIVE/FORMALIN
K831061 · American Micro Scan · Jun 1983
FA TISSUE FIXATIVE & WASH SET
K761138 · Zeus Scientific, Inc. · Jan 1978