Cleared Traditional

K070921 - BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG

K070921 is an FDA 510(k) clearance for BIONEXIA HCG PREGNANCY CASSETTE AND DIP..., manufactured by Applied Dna Technologies, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K070921 · Applied Dna Technologies, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
88d
Days
Class 2
Risk

K070921 is an FDA 510(k) clearance for the BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Applied Dna Technologies, Inc. (Mission Viejo, US). The FDA issued a Cleared decision on June 29, 2007 after a review of 88 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 Applied Dna Technologies, Inc. devices

FDA 510(k) Submission Details - K070921

510(k) Number K070921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2007
Decision Date June 29, 2007
Days to Decision 88 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
At panel average
Panel avg: 88d · This submission: 88d
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 293
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K070921.
HOME PREGNANCY TEST
K112315 · Newscen Coast Bio-Pharmaceutical Co., Ltd. · Apr 2012
RAPIDVUE HCG TEST
K102175 · Quidel Corporation · Aug 2010
FASTPACK HCG IMMUNOASSAY
K072264 · Qualigen, Inc. · Dec 2007
BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC
K071030 · Applied Dna Technologies, Inc. · Jun 2007
DBEST HCG PANEL TEST KIT
K061257 · Ameritek USA, Inc. · May 2007
INNOVACON HCG UKTRA TEST DEVICE
K062361 · Innovacon, Inc. · Oct 2006