Cleared Traditional

K881015 - FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT

K881015 is an FDA 510(k) clearance for FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT, manufactured by Pacific Biotech, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K881015 · Pacific Biotech, Inc. · Chemistry device
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Aug 1988
Decision
172d
Days
Class 2
Risk

K881015 is an FDA 510(k) clearance for the FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Pacific Biotech, Inc. (San Diego, US). The FDA issued a Cleared decision on August 29, 1988 after a review of 172 days - an extended review cycle.

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 Pacific Biotech, Inc. devices

FDA 510(k) Submission Details - K881015

510(k) Number K881015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1988
Decision Date August 29, 1988
Days to Decision 172 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
84d slower than avg
Panel avg: 88d · This submission: 172d
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 290
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K881015.
CIBA CORNING MAGIC LITE HCG IMMUNOASSAY
K883927 · Ciba Corning Diagnostics Corp. · Oct 1988
MODIFIED HCG IRMA KIT
K883639 · Pacific Biotech, Inc. · Oct 1988
CLEARVIEW HCG
K883777 · Unipath , Ltd. · Oct 1988
COTUBE HCG IRMA TEST
K882155 · Bio-Rad · Aug 1988
QTEST(TM) PREGNANCY
K882086 · Quidel Corp. · Jul 1988
IMMUNOCARD(TM) HCG II TEST KIT
K881709 · Disease Detection International, Inc. · Jul 1988