Cleared Traditional

K884146 - ALBUWELL

K884146 is an FDA 510(k) clearance for ALBUWELL, manufactured by Exocell, Inc.. The device is a Class 1 Chemistry device with product code JIR cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K884146 · Exocell, Inc. · Chemistry device
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Jan 1989
Decision
112d
Days
Class 1
Risk

K884146 is an FDA 510(k) clearance for the ALBUWELL. Classified as Indicator Method, Protein Or Albumin (urinary, Non-quant.) (product code JIR), Class I - General Controls.

Submitted by Exocell, Inc. (Philadelphia, US). The FDA issued a Cleared decision on January 23, 1989 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1645 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Exocell, Inc. devices

FDA 510(k) Submission Details - K884146

510(k) Number K884146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1988
Decision Date January 23, 1989
Days to Decision 112 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 88d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

JIR Device Classification - Class 1, General Controls

Product Code JIR Indicator Method, Protein Or Albumin (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1645
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 - JIR Indicator Method, Protein Or Albumin (urinary, Non-quant.)

All 31
Devices cleared under the same product code (JIR) and FDA review panel - the closest regulatory comparables to K884146.
BIOTEL MICROALBUMINURIA (TM)
K894169 · American Diagnostic Corp. · Sep 1989
BIOTROL URINE PROTEINS REAGENT
K890846 · Biotrol, USA, Inc. · Mar 1989
BIOTROL URINE PROTEINS REAGENT
K885053 · Biotrol, USA, Inc. · Jan 1989
MICRO-BUMINTEST REAGENT TABLETS
K874909 · Miles Laboratories, Inc. · Apr 1988
DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI
K851338 · Diagnostic Products Corp. · Apr 1986
HELENA BIOSTRIP P
K830977 · Helena Laboratories · Apr 1983