Cleared Traditional

K891299 - MID-LEVEL IGG KIT CAT. NO. 9315 (FDA 510(k) Clearance)

Class I Immunology device.

K891299 · Helena Laboratories · Immunology device
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Mar 1989
Decision
9d
Days
Class 1
Risk

K891299 is an FDA 510(k) clearance for the MID-LEVEL IGG KIT CAT. NO. 9315. Classified as Igg (fd Fragment Specific), Antigen, Antiserum, Control (product code DAQ), Class I - General Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on March 22, 1989 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5540 - the FDA immunology device 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 Helena Laboratories devices

Submission Details

510(k) Number K891299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1989
Decision Date March 22, 1989
Days to Decision 9 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 104d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DAQ Igg (fd Fragment Specific), Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5540
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.