Cleared Traditional

K854358 - EZ DETECH-URINE BLOOD TEST STICKS

K854358 is an FDA 510(k) clearance for EZ DETECH-URINE BLOOD TEST STICKS, manufactured by Self Care Systems, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K854358

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.

KHE Device Classification - Class 2, Special Controls

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 62
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