Cleared Traditional

K800916 - P1 BLOOD GROUP SUBSTANCE

K800916 is an FDA 510(k) clearance for P1 BLOOD GROUP SUBSTANCE, manufactured by Travenol Laboratories, S.A.. The device is a Class 2 Hematology device with product code KSX cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K800916 · Travenol Laboratories, S.A. · Hematology device
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May 1980
Decision
16d
Days
Class 2
Risk

K800916 is an FDA 510(k) clearance for the P1 BLOOD GROUP SUBSTANCE. Classified as Substance, Blood Grouping Of Non-human Origin For In Vitro Diagnostic Use (product code KSX), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Mchenry, US). The FDA issued a Cleared decision on May 8, 1980 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9160 - 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 Travenol Laboratories, S.A. devices

FDA 510(k) Submission Details - K800916

510(k) Number K800916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1980
Decision Date May 08, 1980
Days to Decision 16 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 113d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KSX Device Classification - Class 2, Special Controls

Product Code KSX Substance, Blood Grouping Of Non-human Origin For In Vitro Diagnostic Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9160
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 - KSX Substance, Blood Grouping Of Non-human Origin For In Vitro Diagnostic Use

Devices cleared under the same product code (KSX) and FDA review panel - the closest regulatory comparables to K800916.
GAMMA LEWIS BLOOD GROUP SUBSTANCE
K802533 · Gamma Biologicals, Inc. · Nov 1980
GAMMA PI BLOOD GROUP SUBSTANCE
K802534 · Gamma Biologicals, Inc. · Nov 1980
LEWIS BLOOD GROUP SUBSTANCE
K771487 · Ortho Diagnostics, Inc. · Nov 1977
P1 BLOOD GROUP SUBSTANCE
K771488 · Ortho Diagnostics, Inc. · Nov 1977