Cleared Traditional

K012559 - POLY STAT HCG TEST

K012559 is an FDA 510(k) clearance for POLY STAT HCG TEST, manufactured by Bion Diagnostic Sciences. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K012559 · Bion Diagnostic Sciences · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
69d
Days
Class 2
Risk

K012559 is an FDA 510(k) clearance for the POLY STAT HCG TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Bion Diagnostic Sciences (Redmond, US). The FDA issued a Cleared decision on October 16, 2001 after a review of 69 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 Bion Diagnostic Sciences devices

FDA 510(k) Submission Details - K012559

510(k) Number K012559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2001
Decision Date October 16, 2001
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 88d · This submission: 69d
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 284
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K012559.
QUICKVUE ONE-STEP HCG-COMBO
K020801 · Quidel Corp. · May 2002
SAS VALUE HCG
K020438 · Sa Scientific, Inc. · Mar 2002
ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500
K020128 · Diagnostic Systems Laboratories, Inc. · Mar 2002
SUREVUE URINE HCG
K010522 · Sa Scientific, Inc. · Jul 2001
SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT
K010593 · Sa Scientific, Inc. · Apr 2001
DBEST HCG 2 IU/ML TEST KIT
K001215 · Ameritek, Inc. · Jun 2000