Cleared Traditional

K961317 - SYPHILIS IGM HUMAN SERUM CONTROLS

K961317 is an FDA 510(k) clearance for SYPHILIS IGM HUMAN SERUM CONTROLS, manufactured by Pyramid Biological Corp.. The device is a Class 2 Microbiology device with product code LIP cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K961317 · Pyramid Biological Corp. · Microbiology device
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Jun 1996
Decision
80d
Days
Class 2
Risk

K961317 is an FDA 510(k) clearance for the SYPHILIS IGM HUMAN SERUM CONTROLS. Classified as Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (product code LIP), Class II - Special Controls.

Submitted by Pyramid Biological Corp. (Van Nuys, US). The FDA issued a Cleared decision on June 24, 1996 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3830 - the FDA microbiology 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.

FDA 510(k) Submission Details - K961317

510(k) Number K961317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1996
Decision Date June 24, 1996
Days to Decision 80 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 102d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIP Device Classification - Class 2, Special Controls

Product Code LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3830
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 Microbiology devices follow this clearance model.

Regulatory Peers - LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

All 33
Devices cleared under the same product code (LIP) and FDA review panel - the closest regulatory comparables to K961317.
CAPTIA SYPHILIS-G ELISA TEST SYSTEM
K001525 · Trinity Biotech, Plc · Nov 2000
TREPCHEK TREPONEMAL ANTIBODY EIA
K001552 · Phoenix Biotech Corp. · Oct 2000
COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY
K992552 · DiaSorin, Inc. · Dec 1999
SYPHILIS IGG HUMAN SERUM CONTROLS
K960493 · Pyramid Biological Corp. · Jun 1996
VISUWELL SYPHILIS ANTIBODY
K932453 · Biomira Diagnostics, Inc. · Jul 1995
VISUWELL SYPHILIS ANTIGEN
K910487 · Adi Diagnostics, Inc. · Jun 1991
K961317 · SYPHILIS IGM HUMAN SERUM CONTROLS
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