Cleared Traditional

K854358 - EZ DETECH-URINE BLOOD TEST STICKS

K854358 is the FDA 510(k) clearance for EZ DETECH-URINE BLOOD TEST STICKS by Self Care Systems, Inc.. It is a Class 2 Chemistry device (product code KHE) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K854358 · Self Care Systems, Inc. · Chemistry device
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Apr 1986
Decision
162d
Days
Class 2
Risk

K854358 is an FDA 510(k) clearance for the EZ DETECH-URINE BLOOD TEST STICKS. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Self Care Systems, Inc. (Newport Beach, US). The FDA issued a Cleared decision on April 9, 1986 after a review of 162 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.6550 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Self Care Systems, Inc. devices

Submission Details

510(k) Number K854358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1985
Decision Date April 09, 1986
Days to Decision 162 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 88d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHE Reagent, Occult Blood
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6550
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 - KHE Reagent, Occult Blood

All 30
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K854358.
WAKO(TM) PRETEST 6A
K873409 · Wako Chemicals USA, Inc. · Feb 1988
HEMOCCULT WIPE TEST
K862849 · Smithkline Diagnostics, Inc. · Dec 1986
BIOTEL (TM)/ KIDNEY
K855237 · American Diagnostic Corp. · May 1986
UROPAPER EIKEN 8
K843532 · Syn-Kit, Inc. · Dec 1984
COLOSCREEN SELF-TEST
K843352 · Helena Laboratories · Dec 1984
HELENA COLOSCREEN SELF-TEST
K840903 · Helena Laboratories · Aug 1984