Cleared Traditional

URINARY/CSF PROTEIN (K913615) - FDA 510(k) Clearance

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

K913615 · Boehringer Mannheim Corp. · Chemistry device
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Sep 1991
Decision
31d
Days
Class 2
Risk

K913615 is an FDA 510(k) clearance for the URINARY/CSF PROTEIN. Classified as Turbidimetric, Total Protein (product code JGQ), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 13, 1991 after a review of 31 days - a notably fast clearance cycle.

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: 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 Boehringer Mannheim Corp. devices

Submission Details

510(k) Number K913615 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1991
Decision Date September 13, 1991
Days to Decision 31 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
57d faster than avg
Panel avg: 88d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 8
Devices cleared under the same product code (JGQ) and FDA review panel - the closest regulatory comparables to K913615.
TOTAL PROTEIN URINE/CSF GEN.3
K071239 · Roche Diagnostics · Sep 2007
UPRO
K981295 · Abbott Laboratories · Oct 1998
UPRO
K981682 · Abbott Laboratories · Sep 1998
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
CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95
K863478 · Em Diagnostic Systems, Inc. · Oct 1986