Cleared Traditional

K803094 - COPPER SULFATE SOLUTION SP. GR.1.053

K803094 is an FDA 510(k) clearance for COPPER SULFATE SOLUTION SP. GR.1.053, manufactured by Accra Laboratories, Inc.. The device is a Class 2 Hematology device with product code KLS cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K803094 · Accra Laboratories, Inc. · Hematology device
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Mar 1981
Decision
88d
Days
Class 2
Risk

K803094 is an FDA 510(k) clearance for the COPPER SULFATE SOLUTION SP. GR.1.053. Classified as Enzyme Immunoassay, Theophylline (product code KLS), Class II - Special Controls.

Submitted by Accra Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 6, 1981 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.3880 - 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 Accra Laboratories, Inc. devices

FDA 510(k) Submission Details - K803094

510(k) Number K803094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1980
Decision Date March 06, 1981
Days to Decision 88 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
25d faster than avg
Panel avg: 113d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLS Device Classification - Class 2, Special Controls

Product Code KLS Enzyme Immunoassay, Theophylline
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3880
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 - KLS Enzyme Immunoassay, Theophylline

All 61
Devices cleared under the same product code (KLS) and FDA review panel - the closest regulatory comparables to K803094.
DETECTION OF THEOPHYLLINE
K821544 · Electro-Nucleonics Laboratories, Inc. · Jun 1982
A-GENT THEOPHYLLINE
K812003 · Abbott Laboratories · Jul 1981
BECKMAN THEOPHYLLINE REAGENT TEST KIT
K810578 · Beckman Instruments, Inc. · Mar 1981
ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY
K802066 · Immunotech Corp. · Oct 1980
FIAX TEST KIT FOR THEOPHYLLINE QUANT.
K801642 · Intl. Diagnostic Technology · Aug 1980
APPLICATION OF EMIT THEOPHYLLINE ASSAY
K801476 · Syva Co. · Jul 1980