Cleared Traditional

K861159 - SPECTRO VWF

K861159 is the FDA 510(k) clearance for SPECTRO VWF by Ramco Laboratories, Inc.. It is a Class 2 Hematology device (product code GGP) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K861159 · Ramco Laboratories, Inc. · Hematology device
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May 1986
Decision
34d
Days
Class 2
Risk

K861159 is an FDA 510(k) clearance for the SPECTRO VWF. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Ramco Laboratories, Inc. (Houston, US). The FDA issued a Cleared decision on May 1, 1986 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - the FDA hematology 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 Ramco Laboratories, Inc. devices

Submission Details

510(k) Number K861159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1986
Decision Date May 01, 1986
Days to Decision 34 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 113d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 Hematology devices follow this clearance model.

Regulatory Peers - GGP Test, Qualitative And Quantitative Factor Deficiency

All 127
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K861159.
HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA
K861049 · Sigma Chemical Co. · May 1986
VWF-IX:AG CONTROL PLASMA
K861217 · American Bioproducts Co. · May 1986
PROTEIN C CONTROL PLASMA
K861216 · American Bioproducts Co. · May 1986
ASSERACHROM VWF KIT
K860371 · American Bioproducts Co. · Apr 1986
ASSERACHROM IX:AG
K854312 · American Bioproducts Co. · Feb 1986
ASSERA PLATE IX:AG KIT
K854014 · American Bioproducts Co. · Jan 1986