Cleared Traditional

WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180 (K932661) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K932661 · Whatman Specialty Products, Inc. · Chemistry device
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Apr 1996
Decision
1050d
Days
Class 2
Risk

K932661 is an FDA 510(k) clearance for the WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180. Classified as Newborn Screening Specimen Collection Paper (product code PJC), Class II - Special Controls.

Submitted by Whatman Specialty Products, Inc. (Fairfield, US). The FDA issued a Cleared decision on April 17, 1996 after a review of 1050 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1675 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Whatman Specialty Products, Inc. devices

Submission Details

510(k) Number K932661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1993
Decision Date April 17, 1996
Days to Decision 1050 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
962d slower than avg
Panel avg: 88d · This submission: 1050d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PJC Newborn Screening Specimen Collection Paper
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
Definition Newborn Screening Specimen Collection Paper Is A Blood Collection Device Intended To Be Used As Medium To Collect And Transport Whole Blood Specimens From Newborns To The Laboratory For In Vitro Diagnostic Analysis.
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.