Cleared Traditional

MODIFICATION OF ABL MIC-10 PRECEPT SYS (K843612) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K843612 · Austin Biological Laboratories · Microbiology device
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Feb 1985
Decision
159d
Days
Class 3
Risk

K843612 is an FDA 510(k) clearance for the MODIFICATION OF ABL MIC-10 PRECEPT SYS. Classified as Paraquat Assay (product code LTD), Class III - Premarket Approval.

Submitted by Austin Biological Laboratories (Austin, US). The FDA issued a Cleared decision on February 19, 1985 after a review of 159 days - an extended review cycle.

This device falls under the Microbiology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K843612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1984
Decision Date February 19, 1985
Days to Decision 159 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 102d · This submission: 159d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LTD Paraquat Assay
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.