Cleared Traditional

K941130 - ASSURE URINE HCG CONTROL

K941130 is an FDA 510(k) clearance for ASSURE URINE HCG CONTROL, manufactured by Quantimetrix Corp.. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K941130 · Quantimetrix Corp. · Chemistry device
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Jun 1994
Decision
86d
Days
Class 1
Risk

K941130 is an FDA 510(k) clearance for the ASSURE URINE HCG CONTROL. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Quantimetrix Corp. (Hawthorne, US). The FDA issued a Cleared decision on June 3, 1994 after a review of 86 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 Quantimetrix Corp. devices

FDA 510(k) Submission Details - K941130

510(k) Number K941130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1994
Decision Date June 03, 1994
Days to Decision 86 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
2d faster than avg
Panel avg: 88d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

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 418
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K941130.
HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH
K941433 · Hichem Diagnostics · Aug 1994
AXSYM LUTEINIZING HORMONE (LH)
K935611 · Abbott Laboratories · Jun 1994
GLUCOMETER ELITE LOW CONTROL
K940577 · Heraeus Kulzer, Inc. · 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 HCG URINE CONTROL SET
K934922 · Unipath , Ltd. · Dec 1993