Cleared Traditional

K923030 - ANI BIOCARD HCG TEST

K923030 is an FDA 510(k) clearance for ANI BIOCARD HCG TEST, manufactured by Ani OY. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K923030 · Ani OY · Chemistry device
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Sep 1992
Decision
84d
Days
Class 2
Risk

K923030 is an FDA 510(k) clearance for the ANI BIOCARD HCG TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Ani OY (Canada M1x 1b4, CA). The FDA issued a Cleared decision on September 15, 1992 after a review of 84 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 Ani OY devices

FDA 510(k) Submission Details - K923030

510(k) Number K923030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1992
Decision Date September 15, 1992
Days to Decision 84 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
4d faster than avg
Panel avg: 88d · This submission: 84d
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 294
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K923030.
QUICKVUE ONE-STEP HCG TEST
K925435 · Quidel Corp. · Dec 1992
MEDIX BIOTECH BESTEST(TM) HCG-URINE, CAT# B1H0100
K924259 · Medix Biotech, Inc. · Nov 1992
VISUAL HCG PREGNANCY TEST
K923376 · Tech-Co, Inc. · Oct 1992
DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD
K922697 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1992
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K921302 · Vitek Systems, Inc. · Jul 1992
SINGLE-STEP PREGNANCY, HCG TEST
K922290 · American Medical Products, Inc. · Jul 1992