Cleared Traditional

K934922 - CLEARVIEW POSITIVE AND NEGATIVE HCG URI...

K934922 is the FDA 510(k) clearance for CLEARVIEW POSITIVE AND NEGATIVE HCG URI... by Unipath , Ltd.. It is a Class 1 Chemistry device (product code JJX) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K934922 · Unipath , Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
77d
Days
Class 1
Risk

K934922 is an FDA 510(k) clearance for the CLEARVIEW POSITIVE AND NEGATIVE HCG URINE CONTROL SET. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Unipath , Ltd. (Bedford Mk41 Oqg, GB). The FDA issued a Cleared decision on December 29, 1993 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Unipath , Ltd. devices

Submission Details

510(k) Number K934922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1993
Decision Date December 29, 1993
Days to Decision 77 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 88d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 370
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K934922.
ASSURE URINE HCG CONTROL
K941130 · Quantimetrix Corp. · Jun 1994
ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL
K940272 · Analytical Control Systems, Inc. · Apr 1994
DOCUMENT(R) ZERO
K940568 · Casco Standards · Apr 1994
CLEARVIEW POSITIVE AND NEGATIVE URINE HCG CONTOL SET
K934923 · Unipath , Ltd. · Dec 1993
SPQ MALB CONTROL LEVEL II
K934521 · Incstar Corp. · Nov 1993
SAS(TM) HCG URINE CONTROLS, VARIOUS SIZES
K933744 · Sa Scientific, Inc. · Sep 1993