Cleared Traditional

K875354 - UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM

K875354 is an FDA 510(k) clearance for UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM, manufactured by Ulster Scientific, Inc.. The device is a Class 2 Hematology device with product code LCP cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K875354 · Ulster Scientific, Inc. · Hematology device
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Feb 1988
Decision
48d
Days
Class 2
Risk

K875354 is an FDA 510(k) clearance for the UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM. Classified as Assay, Glycosylated Hemoglobin (product code LCP), Class II - Special Controls.

Submitted by Ulster Scientific, Inc. (Highland, US). The FDA issued a Cleared decision on February 17, 1988 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7470 - 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.

View all Ulster Scientific, Inc. devices

FDA 510(k) Submission Details - K875354

510(k) Number K875354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 1987
Decision Date February 17, 1988
Days to Decision 48 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
65d faster than avg
Panel avg: 113d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCP Device Classification - Class 2, Special Controls

Product Code LCP Assay, Glycosylated Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7470
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 Hematology devices follow this clearance model.

Regulatory Peers - LCP Assay, Glycosylated Hemoglobin

All 188
Devices cleared under the same product code (LCP) and FDA review panel - the closest regulatory comparables to K875354.
DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY
K882222 · Bio-Rad · Aug 1988
TITAN GEL-PC GLYCO-HEME(TM) SYSTEM
K880698 · Helena Laboratories · May 1988
GLYCO-PROBE GSP
K873428 · Isolab, Inc. · Apr 1988
FRUCTOSAMINE TEST (ROCHE)
K854010 · Roche Diagnostic Systems, Inc. · Dec 1987
EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST
K872852 · Sandare Chemical Co., Inc. · Sep 1987
FOCUS-GHB
K871679 · Awareness Technology, Inc. · Jul 1987