Cleared Traditional

K973702 - ELECSYS VITAMIN B12 ASSAY

K973702 is an FDA 510(k) clearance for ELECSYS VITAMIN B12 ASSAY, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Chemistry device with product code CDD cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K973702 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
48d
Days
Class 2
Risk

K973702 is an FDA 510(k) clearance for the ELECSYS VITAMIN B12 ASSAY. Classified as Radioassay, Vitamin B12 (product code CDD), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Pleasanton, US). The FDA issued a Cleared decision on November 13, 1997 after a review of 48 days - a notably fast clearance cycle.

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: 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K973702

510(k) Number K973702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1997
Decision Date November 13, 1997
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 88d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDD Device Classification - Class 2, Special Controls

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 56
Devices cleared under the same product code (CDD) and FDA review panel - the closest regulatory comparables to K973702.
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS
K013899 · Ortho-Clinical Diagnostics · Jan 2002
BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12
K993571 · Bayer Corp. · Dec 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS
K984321 · Ortho-Clinical Diagnostics, Inc. · Jan 1999
ELECSYS FOLATE
K973674 · Boehringer Mannheim Corp. · Nov 1997
IMMULITE VITAMIN B12 (LKVB1,LKVB5)
K971177 · Diagnostic Products Corp. · May 1997
AXSYM B12
K965186 · Abbott Laboratories · Mar 1997