Cleared Traditional

K870890 - ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT

K870890 is an FDA 510(k) clearance for ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT, manufactured by Helena Laboratories. The device is a Class 2 Chemistry device with product code CIN cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K870890 · Helena Laboratories · Chemistry device
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Jun 1987
Decision
88d
Days
Class 2
Risk

K870890 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT. Classified as Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (product code CIN), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on June 1, 1987 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - the FDA in vitro diagnostics and chemistry 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

FDA 510(k) Submission Details - K870890

510(k) Number K870890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1987
Decision Date June 01, 1987
Days to Decision 88 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 88d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIN Device Classification - Class 2, Special Controls

Product Code CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1050
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 Chemistry devices follow this clearance model.

Regulatory Peers - CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

All 22
Devices cleared under the same product code (CIN) and FDA review panel - the closest regulatory comparables to K870890.
ALKALINE PHOSPHATASE ISOENZYME REAGENTS
K890269 · Beckman Instruments, Inc. · Mar 1989
TITAN GEL ALKALINE PHOSPHATASE (HR)
K885341 · Helena Laboratories · Feb 1989
ALKALINE PHOSPHATASE ISOENZYME SYSTEM
K885024 · Ciba Corning Diagnostics Corp. · Feb 1989
ALKALINE PHOSPHATES ISOENZYME SUBSTRATE
K830118 · Corning Medical & Scientific · Feb 1983
ALKALINE PHOSPHATASE MARKER
K792548 · Electrophoresis Corp. of America · Jan 1980
ALKALINE PHOSPHATASE ISOENZY. SUB. SET
K771620 · Pfizer, Inc. · Sep 1977