Cleared Traditional

K874388 - KODAK SURECELL(TM) HCG-URINE KIT

K874388 is an FDA 510(k) clearance for KODAK SURECELL(TM) HCG-URINE 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 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

FDA 510(k) Submission Details - K874388

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.

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 K874388.
HUMAN CHORIONIC GONADOTROPIN VISUAL TEST KIT
K880410 · Disease Detection International, Inc. · Apr 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
CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504
K873788 · Pacific Biotech, Inc. · Nov 1987
VENTRESCREEN, HCG URINE
K874258 · Ventrex Laboratories, Inc. · Nov 1987