Cleared Traditional

K880745 - LX-100 SLIDE STAINER

K880745 is an FDA 510(k) clearance for LX-100 SLIDE STAINER, manufactured by Innovative Medical Systems, Inc.. The device is a Class 1 Hematology device with product code KPA cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K880745 · Innovative Medical Systems, Inc. · Hematology device
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Apr 1988
Decision
63d
Days
Class 1
Risk

K880745 is an FDA 510(k) clearance for the LX-100 SLIDE STAINER. Classified as Slide Stainer, Automated (product code KPA), Class I - General Controls.

Submitted by Innovative Medical Systems, Inc. (Ivyland, US). The FDA issued a Cleared decision on April 27, 1988 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.3800 - the FDA hematology 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.

FDA 510(k) Submission Details - K880745

510(k) Number K880745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1988
Decision Date April 27, 1988
Days to Decision 63 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 113d · This submission: 63d
Pathway characteristics
Predicate-based equivalence.

KPA Device Classification - Class 1, General Controls

Product Code KPA Slide Stainer, Automated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3800
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 - KPA Slide Stainer, Automated

All 20
Devices cleared under the same product code (KPA) and FDA review panel - the closest regulatory comparables to K880745.
PROFIBLOT
K933996 · Tecan U.S., Ltd. · Jan 1994
VERSABLOT
K884258 · American Bionetics, Inc. · Dec 1988
WESCOR MODEL 7300 AEROSPRAY GRAM STAINER
K881592 · Wescor, Inc. · May 1988
WESBLOT PROCESSOR
K874887 · American Bionetics, Inc. · Mar 1988
SAKURA DRS-60 AUTOMATIC SLIDE STAINER
K874897 · Sakura Finetek U.S.A., Inc. · Jan 1988
HISTOMATIC SLIDE STAINER, CODE-ON VERSION
K872916 · Fisher Scientific Co., LLC · Sep 1987
K880745 · LX-100 SLIDE STAINER
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