Cleared Traditional

K873409 - WAKO(TM) PRETEST 6A

K873409 is an FDA 510(k) clearance for WAKO(TM) PRETEST 6A, manufactured by Wako Chemicals USA, Inc.. The device is a Class 2 Chemistry device with product code KHE cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K873409 · Wako Chemicals USA, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1988
Decision
170d
Days
Class 2
Risk

K873409 is an FDA 510(k) clearance for the WAKO(TM) PRETEST 6A. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Dallas, US). The FDA issued a Cleared decision on February 11, 1988 after a review of 170 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 Wako Chemicals USA, Inc. devices

FDA 510(k) Submission Details - K873409

510(k) Number K873409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1987
Decision Date February 11, 1988
Days to Decision 170 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
82d slower than avg
Panel avg: 88d · This submission: 170d
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 53
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K873409.
HELENA COLOCARE
K882799 · Helena Laboratories · Sep 1988
IMMUNOCCULT EIA TEST KIT
K871143 · Intl. Immunoassay Laboratories, Inc. · Jul 1988
HEMOCCULT SENSITIVE TEST
K880499 · Smithkline Diagnostics, Inc. · May 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