Cleared Traditional

K894175 - SRI HUMAN CHORIONIC GONADOTROPIN IMMUNO...

K894175 is the FDA 510(k) clearance for SRI HUMAN CHORIONIC GONADOTROPIN IMMUNO... by Serono-Baker Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K894175 · Serono-Baker Diagnostics, Inc. · Chemistry device
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Dec 1989
Decision
187d
Days
Class 2
Risk

K894175 is an FDA 510(k) clearance for the SRI HUMAN CHORIONIC GONADOTROPIN IMMUNOENZ ASSAY. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Serono-Baker Diagnostics, Inc. (Allentown, US). The FDA issued a Cleared decision on December 19, 1989 after a review of 187 days - an extended review 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: 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 Serono-Baker Diagnostics, Inc. devices

Submission Details

510(k) Number K894175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1989
Decision Date December 19, 1989
Days to Decision 187 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 88d · This submission: 187d
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 183
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K894175.
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ENZYMUN TEST R HCG
K896901 · Boehringer Mannheim Corp. · Feb 1990
MILENIA(TM) HCG (MKCG1,5)
K895809 · Diagnostic Products Corp. · Dec 1989
QUIDEL HCG TEST
K894790 · Quidel Corp. · Oct 1989
COAT-A-COUNT (TM) HCG IRMA
K894941 · Diagnostic Products Corp. · Oct 1989