Cleared Traditional

K973040 - SPIFE IFE-6

K973040 is an FDA 510(k) clearance for SPIFE IFE-6, manufactured by Helena Laboratories. The device is a Class 2 Chemistry device with product code CFF cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K973040 · Helena Laboratories · Chemistry device
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Jan 1998
Decision
141d
Days
Class 2
Risk

K973040 is an FDA 510(k) clearance for the SPIFE IFE-6. Classified as Immunoelectrophoretic, Immunoglobulins, (g, A, M) (product code CFF), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on January 2, 1998 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5510 - 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 Helena Laboratories devices

FDA 510(k) Submission Details - K973040

510(k) Number K973040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1997
Decision Date January 02, 1998
Days to Decision 141 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 88d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFF Device Classification - Class 2, Special Controls

Product Code CFF Immunoelectrophoretic, Immunoglobulins, (g, A, M)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - CFF Immunoelectrophoretic, Immunoglobulins, (g, A, M)

All 26
Devices cleared under the same product code (CFF) and FDA review panel - the closest regulatory comparables to K973040.
K-ASSAY IGA
K993213 · Kamiya Biomedical Co. · Nov 1999
POLYSLIT IFE KIT
K990998 · Helena Laboratories · Jun 1999
HYDRAGEL 6 CSF KIT
K981048 · Morax · Oct 1998
HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS
K960669 · Morax · Jul 1996
N-ASSAY TIA IGG
K933972 · Crestat Diagnostics, Inc. · Mar 1994
IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC
K924767 · The Binding Site, Ltd. · Feb 1993