Cleared Traditional

CANWEST-PREGBLUE (K854989) - FDA 510(k) Clearance

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

K854989 · Canwest Medictex, Inc. · Chemistry device
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Jan 1986
Decision
32d
Days
Class 2
Risk

K854989 is an FDA 510(k) clearance for the CANWEST-PREGBLUE. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Canwest Medictex, Inc. (Vancouver B.C., CA). The FDA issued a Cleared decision on January 13, 1986 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - 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.

View all Canwest Medictex, Inc. devices

Submission Details

510(k) Number K854989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1985
Decision Date January 13, 1986
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
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.

Regulatory Peers - JHI Visual, Pregnancy Hcg, Prescription Use

All 59
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K854989.
COAT-A-COUNT IRMA HCG KIT AND ITS COMPONENTS
K870106 · Diagnostic Products Corp. · Mar 1987
HCG SOLID PHASE COMPONENT SYSTEM
K864591 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1987
ABBOTT TESTPACK (TM) HCG SERUM
K863032 · Abbott Laboratories · Sep 1986
ABBOTT TESTPACK HCG(URINE) DIAGNOSTIC KIT
K853539 · Abbott Laboratories · Sep 1985
BETA HCG EXTENDED RANGE ACCESSORY KIT
K852183 · Abbott Laboratories · Jul 1985
ECHOCLONAL HCG IRMA
K852201 · Bio-Rad · Jun 1985