Cleared Traditional

K895809 - MILENIA(TM) HCG (MKCG1,5)

K895809 is an FDA 510(k) clearance for MILENIA(TM) HCG (MKCG1, manufactured by Diagnostic Products Corp.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K895809 · Diagnostic Products Corp. · Chemistry device
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Dec 1989
Decision
90d
Days
Class 2
Risk

K895809 is an FDA 510(k) clearance for the MILENIA(TM) HCG (MKCG1,5). Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on December 1, 1989 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K895809

510(k) Number K895809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1989
Decision Date December 01, 1989
Days to Decision 90 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 88d · This submission: 90d
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 282
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K895809.
MODIFIED HCG ENZYME IMMUNOASSAY TEST KIT
K896587 · Medix Biotech, Inc. · Feb 1990
ENZYMUN TEST R HCG
K896901 · Boehringer Mannheim Corp. · Feb 1990
SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY
K894175 · Serono-Baker Diagnostics, Inc. · Dec 1989
IMMUNOCARD HCG II-S TEST KIT
K895912 · Disease Detection International, Inc. · Dec 1989
CARDS O.S. (TM) HCG-URINE
K895390 · Pacific Biotech, Inc. · Nov 1989
QUIDEL HCG TEST
K894790 · Quidel Corp. · Oct 1989