Cleared Traditional

K853258 - BETA-HCG MICROTITER PREGNANCY TEST

K853258 is the FDA 510(k) clearance for BETA-HCG MICROTITER PREGNANCY TEST by Modern Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K853258 · Modern Diagnostics, Inc. · Chemistry device
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Oct 1985
Decision
60d
Days
Class 2
Risk

K853258 is an FDA 510(k) clearance for the BETA-HCG MICROTITER PREGNANCY TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Modern Diagnostics, Inc. (Sacramento, US). The FDA issued a Cleared decision on October 1, 1985 after a review of 60 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 Modern Diagnostics, Inc. devices

Submission Details

510(k) Number K853258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1985
Decision Date October 01, 1985
Days to Decision 60 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 88d · This submission: 60d
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 187
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K853258.
TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT
K860542 · Hybritech, Inc. · Mar 1986
LBK 1244 DELFIA HCG KIT
K852760 · Lkb Instruments, Inc. · Dec 1985
CORNING MAGIC MAB HCG RADIOIMMUNOASSAY
K854024 · Corning Medical & Scientific · Nov 1985
ABBOTT TESTPACK HCG(URINE) DIAGNOSTIC KIT
K853539 · Abbott Laboratories · Sep 1985
AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT
K852675 · Amersham Corp. · Jul 1985
BETA HCG EXTENDED RANGE ACCESSORY KIT
K852183 · Abbott Laboratories · Jul 1985