Cleared Traditional

K850992 - PREGNA-ZYME

K850992 is the FDA 510(k) clearance for PREGNA-ZYME by Armkel, LLC. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K850992 · Armkel, LLC · Chemistry device
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May 1985
Decision
51d
Days
Class 2
Risk

K850992 is an FDA 510(k) clearance for the PREGNA-ZYME. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on May 1, 1985 after a review of 51 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 Armkel, LLC devices

Submission Details

510(k) Number K850992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1985
Decision Date May 01, 1985
Days to Decision 51 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
37d faster than avg
Panel avg: 88d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 182
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K850992.
BETA HCG EXTENDED RANGE ACCESSORY KIT
K852183 · Abbott Laboratories · Jul 1985
ECHOCLONAL HCG IRMA
K852201 · Bio-Rad · Jun 1985
BHCG-ROCHE EIA
K850727 · Hoffmann-La Roche, Inc. · Jun 1985
MEDIX VISUAL URINE HCG (7/7) TEST
K850949 · Medix Biotech, Inc. · Apr 1985
MEDIX VISUAL SERUMO HCG L10/10 TEST HCG ENZYME IMM
K850987 · Medix Biotech, Inc. · Apr 1985
LEECO CONCEP-7-BHCG IRMA
K850530 · Leeco Diagnostics, Inc. · Apr 1985