Cleared Traditional

K936138 - KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION

K936138 is an FDA 510(k) clearance for KODAK SURECELL HCG-SERUM/URINE TEST KIT, manufactured by Eastman Kodak Company. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K936138 · Eastman Kodak Company · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
106d
Days
Class 2
Risk

K936138 is an FDA 510(k) clearance for the KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Eastman Kodak Company (Rochester, US). The FDA issued a Cleared decision on April 8, 1994 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1155 - 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 Eastman Kodak Company devices

FDA 510(k) Submission Details - K936138

510(k) Number K936138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1993
Decision Date April 08, 1994
Days to Decision 106 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 88d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHI Device Classification - Class 2, Special Controls

Product Code JHI Visual, Pregnancy Hcg, Prescription Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1155
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 - JHI Visual, Pregnancy Hcg, Prescription Use

All 293
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K936138.
BIOSIGN, ACCUSIGN, LIFESIGN, HCG SERUM/URINE
K944426 · Princeton BioMeditech Corp. · Oct 1994
AXSYM TOTAL B-HCG
K935673 · Abbott Laboratories · Jun 1994
ONE STEP PREGNANCY TEST
K936031 · Teco Diagnostics · Apr 1994
KODAK SURECELL HCG URINE TEST, MODIFICATION
K936287 · Eastman Kodak Company · Apr 1994
MEDIX BIOTECH BESTEST HCG-URINE TEST KIT
K932758 · Medix Biotech, Inc. · Sep 1993
OPUS(R) TOTAL B-HCG TEST SYSTEM
K932279 · Pb Diagnostic Systems, Inc. · Jul 1993