Cleared Traditional

K822449 - TPK 1980/1

K822449 is an FDA 510(k) clearance for TPK 1980/1, manufactured by Plantex USA, Inc.. The device is a Class 2 Chemistry device with product code LCX cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K822449 · Plantex USA, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1982
Decision
72d
Days
Class 2
Risk

K822449 is an FDA 510(k) clearance for the TPK 1980/1. Classified as Kit, Test, Pregnancy, Hcg, Over The Counter (product code LCX), Class II - Special Controls.

Submitted by Plantex USA, Inc. (Walker, US). The FDA issued a Cleared decision on October 27, 1982 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - 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 Plantex USA, Inc. devices

FDA 510(k) Submission Details - K822449

510(k) Number K822449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1982
Decision Date October 27, 1982
Days to Decision 72 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
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.

LCX Device Classification - Class 2, Special Controls

Product Code LCX Kit, Test, Pregnancy, Hcg, Over The Counter
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.