Cleared Traditional

K171521 - DUS R-50S (Urine Chemistry system)

K171521 is an FDA 510(k) clearance for DUS R-50S (Urine Chemistry system), manufactured by DFI Co., Ltd.. The device is a Class 2 Chemistry device with product code JIL cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K171521 · DFI Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
268d
Days
Class 2
Risk

K171521 is an FDA 510(k) clearance for the DUS R-50S (Urine Chemistry system). Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by DFI Co., Ltd. (Gyeongsangnam-Do, KR). The FDA issued a Cleared decision on February 16, 2018 after a review of 268 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1340 - 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 DFI Co., Ltd. devices

FDA 510(k) Submission Details - K171521

510(k) Number K171521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2017
Decision Date February 16, 2018
Days to Decision 268 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
180d slower than avg
Panel avg: 88d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIL Device Classification - Class 2, Special Controls

Product Code JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1340
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 Consultant

Onbix Corporation
Ho Dong Yang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)

All 37
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K171521.
DIP/U.S. Urine Analysis Test System
K173327 · Healthy.Io, Ltd. · Jul 2018
inui In-Home Urine Analysis Test System
K180356 · Scanadu, Inc. · May 2018
DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips
K181024 · DFI Co., Ltd. · May 2018
TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS
K141289 · Teco Diagnostics · Jul 2015
URS-2GP (GLUCOSE PROTEIN) URINE STRIPS
K131600 · Teco Diagnostics · May 2014
FORESIGHT U120 URINE ANALYZER
K120124 · ACON Laboratories, Inc. · Mar 2012