Cleared Traditional

K896901 - ENZYMUN TEST R HCG

K896901 is an FDA 510(k) clearance for ENZYMUN TEST R HCG, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K896901 · Boehringer Mannheim Corp. · Chemistry device
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Feb 1990
Decision
62d
Days
Class 2
Risk

K896901 is an FDA 510(k) clearance for the ENZYMUN TEST R HCG. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on February 8, 1990 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - 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

FDA 510(k) Submission Details - K896901

510(k) Number K896901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1989
Decision Date February 08, 1990
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 88d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHI Device Classification - Class 2, Special Controls

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
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 - JHI Visual, Pregnancy Hcg, Prescription Use

All 207
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K896901.
IMX HCG (LIST #03A63)
K900327 · Abbott Laboratories · Apr 1990
HCG SOLID PHASE COMPONENT SYSTEM
K901045 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1990
MODIFIED HCG ENZYME IMMUNOASSAY TEST KIT
K896587 · Medix Biotech, Inc. · Feb 1990
MILENIA(TM) HCG (MKCG1,5)
K895809 · Diagnostic Products Corp. · Dec 1989
CARDS O.S. (TM) HCG-URINE
K895390 · Pacific Biotech, Inc. · Nov 1989
QUIDEL HCG TEST
K894790 · Quidel Corp. · Oct 1989