Cleared Traditional

K981682 - UPRO

K981682 is an FDA 510(k) clearance for UPRO, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code JGQ cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K981682 · Abbott Laboratories · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
131d
Days
Class 2
Risk

K981682 is an FDA 510(k) clearance for the UPRO. Classified as Turbidimetric, Total Protein (product code JGQ), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on September 21, 1998 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1635 - 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K981682

510(k) Number K981682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1998
Decision Date September 21, 1998
Days to Decision 131 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 88d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JGQ Device Classification - Class 2, Special Controls

Product Code JGQ Turbidimetric, Total Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1635
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 - JGQ Turbidimetric, Total Protein

All 9
Devices cleared under the same product code (JGQ) and FDA review panel - the closest regulatory comparables to K981682.
ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801
K072638 · Roche Diagnostics Corp. · Oct 2007
TOTAL PROTEIN URINE/CSF GEN.3
K071239 · Roche Diagnostics · Sep 2007
UPRO
K981295 · Abbott Laboratories · Oct 1998
URINARY/CSF PROTEIN
K913615 · Boehringer Mannheim Corp. · Sep 1991
PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK
K903914 · Baxter Healthcare Corp · Oct 1990
EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95
K901083 · Em Diagnostic Systems, Inc. · Apr 1990