Cleared Traditional

K874388 - KODAK SURECELL(TM) HCG-URINE KIT

K874388 is the FDA 510(k) clearance for KODAK SURECELL(TM) HCG-URINE KIT by Eastman Kodak Company. It is a Class 2 Chemistry device (product code JHI) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K874388 · Eastman Kodak Company · Chemistry device
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Feb 1988
Decision
104d
Days
Class 2
Risk

K874388 is an FDA 510(k) clearance for the KODAK SURECELL(TM) HCG-URINE KIT. 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 February 8, 1988 after a review of 104 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

Submission Details

510(k) Number K874388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1987
Decision Date February 08, 1988
Days to Decision 104 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
16d slower than avg
Panel avg: 88d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 187
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K874388.
QUIDEL PREGNANCY TEST
K881595 · Quidel Corp. · May 1988
ABBOTT IMX HCG
K880070 · Abbott Laboratories · Mar 1988
CONCEP-7-BHCG
K880577 · Leeco Diagnostics, Inc. · Mar 1988
IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X
K874033 · Diagnostic Products Corp. · Jan 1988
VENTRESCREEN, HCG URINE
K874258 · Ventrex Laboratories, Inc. · Nov 1987
RESULT PLUS/HCG PREGNANCY TEST
K872730 · Ortho Diagnostic Systems, Inc. · Oct 1987