Cleared Traditional

K974851 - SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST

K974851 is an FDA 510(k) clearance for SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST, manufactured by San Diego Biotech. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K974851 · San Diego Biotech · Chemistry device
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Jan 1998
Decision
24d
Days
Class 2
Risk

K974851 is an FDA 510(k) clearance for the SAN DIEGO BIOTECH HCG PREGNANCY URINE TEST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by San Diego Biotech (San Diego, US). The FDA issued a Cleared decision on January 22, 1998 after a review of 24 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all San Diego Biotech devices

FDA 510(k) Submission Details - K974851

510(k) Number K974851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1997
Decision Date January 22, 1998
Days to Decision 24 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 88d · This submission: 24d
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 287
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K974851.
AIMSTEP PREGNANCY
K980531 · Germaine Laboratories, Inc. · Mar 1998
SAN DIEGO BIOTECH HCG PREGNANCY DIPSTICK TEST
K980205 · San Diego Biotech · Feb 1998
QUICKSTICK PRO HCG TEST
K974615 · Phamatech · Jan 1998
OSOM HCG-URINE TEST MODEL 101
K974159 · Wyntek Diagnostics, Inc. · Dec 1997
QUICKVUE SEMI-Q HCG-COMBO
K974052 · Quidel Corp. · Dec 1997
DBEST ONE-STEP HCG SERUM/URINE TEST
K973957 · Ameritek, Inc. · Dec 1997