Cleared Traditional

ANTIBODY TO INTRINSIC FACTOR RADIOASSAY (K833142) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K833142 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry device
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Jan 1984
Decision
138d
Days
Class 2
Risk

K833142 is an FDA 510(k) clearance for the ANTIBODY TO INTRINSIC FACTOR RADIOASSAY. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on January 30, 1984 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1810 - 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K833142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1983
Decision Date January 30, 1984
Days to Decision 138 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
50d slower than avg
Panel avg: 88d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDD Radioassay, Vitamin B12
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1810
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 - CDD Radioassay, Vitamin B12

All 29
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K833142.
RADIAS B12 ENZYME IMMUNOASSAY
K933315 · Bio-Rad · Aug 1993
AFFINITY B12
K920078 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992
SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB)
K860815 · Diagnostic Products Corp. · Jul 1986
QUANTAPHASE B-12-COBALMIN-FOLATE-
K833247 · Bio-Rad · Oct 1983
INTRINSIC FACTOR BLOCKING ANTIBODY KIT
K832726 · Diagnostic Products Corp. · Sep 1983
NO-BOIL SOLID PHASE SIMUL TRAC B12
K822721 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1983