Cleared Traditional

K936201 - URINARY ALBUMIN CALIBRATOR

K936201 is an FDA 510(k) clearance for URINARY ALBUMIN CALIBRATOR, manufactured by Dupont Medical Products. The device is a Class 2 Chemistry device with product code JIS cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K936201 · Dupont Medical Products · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
72d
Days
Class 2
Risk

K936201 is an FDA 510(k) clearance for the URINARY ALBUMIN CALIBRATOR. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Dupont Medical Products (N. Billerica, US). The FDA issued a Cleared decision on March 11, 1994 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Dupont Medical Products devices

FDA 510(k) Submission Details - K936201

510(k) Number K936201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1993
Decision Date March 11, 1994
Days to Decision 72 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
16d faster than avg
Panel avg: 88d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIS Device Classification - Class 2, Special Controls

Product Code JIS Calibrator, Primary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIS Calibrator, Primary

All 96
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K936201.
T-UPTAKE CALIBRATORS
K951585 · Diagnostic Reagents, Inc. · Jun 1995
IMX ESTRADIOL
K951629 · Abbott Laboratories · May 1995
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KING SODIUM/POTASSIUM STANDARD MODIFIED
K931834 · King Diagnostics, Inc. · Aug 1993
DC-LINEATE CAT. NO. SE-091
K932555 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1993
DU PONT ACA NEV/EEV VERIFIER
K930501 · Dupont Medical Products · Aug 1993