Cleared Traditional

K895108 - FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM.

K895108 is an FDA 510(k) clearance for FOLLICLE STIMULATING HORMONE MAB SOLID ..., manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 1 Chemistry device with product code CGJ cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K895108 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
69d
Days
Class 1
Risk

K895108 is an FDA 510(k) clearance for the FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM.. Classified as Radioimmunoassay, Follicle-stimulating Hormone (product code CGJ), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on October 23, 1989 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1300 - 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K895108

510(k) Number K895108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1989
Decision Date October 23, 1989
Days to Decision 69 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
19d faster than avg
Panel avg: 88d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

CGJ Device Classification - Class 1, General Controls

Product Code CGJ Radioimmunoassay, Follicle-stimulating Hormone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CGJ Radioimmunoassay, Follicle-stimulating Hormone

All 69
Devices cleared under the same product code (CGJ) and FDA review panel - the closest regulatory comparables to K895108.
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K894761 · Hybritech, Inc. · Sep 1989
COAT-A-COUNT (TM) FSH IRMA
K893976 · Diagnostic Products Corp. · Aug 1989
SR1 (FSH) IMMUNOENZYMETRIC ASSAY
K892706 · Serono-Baker Diagnostics, Inc. · Jun 1989