Cleared Traditional

CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK) (K960800) - FDA 510(k) Clearance

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

K960800 · Boehringer Mannheim Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
150d
Days
Class 2
Risk

K960800 is an FDA 510(k) clearance for the CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK). Classified as Acid, Folic, Radioimmunoassay (product code CGN), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on July 26, 1996 after a review of 150 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1295 - 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 Boehringer Mannheim Corp. devices

Submission Details

510(k) Number K960800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1996
Decision Date July 26, 1996
Days to Decision 150 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
62d slower than avg
Panel avg: 88d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGN Acid, Folic, Radioimmunoassay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1295
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 - CGN Acid, Folic, Radioimmunoassay

All 31
Devices cleared under the same product code (CGN) and FDA review panel - the closest regulatory comparables to K960800.
IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06
K993254 · Diagnostic Products Corp. · Nov 1999
ABBOTT ARCHITECT FOLATE
K984301 · Abbott Laboratories · Feb 1999
ABBOTT AXSYM FOLATE
K972232 · Abbott Laboratories · Jun 1997
ACCESS FOLATE ASSAY (MODIFICATION)
K955434 · Beckman Coulter, Inc. · Jan 1996
RADIAS RED CELL FOLATE IMMUNOASAY
K944212 · Bio-Rad · Feb 1995
FOLIC ACID
K943705 · Diagnostic Products Corp. · Oct 1994