Cleared Traditional

K862007 - HCG IRMA, CAT. NO. CR-1501

K862007 is an FDA 510(k) clearance for HCG IRMA, 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 35-day FDA review.

K862007 · Pacific Biotech, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1986
Decision
35d
Days
Class 2
Risk

K862007 is an FDA 510(k) clearance for the HCG IRMA, CAT. NO. CR-1501. 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 July 1, 1986 after a review of 35 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 Pacific Biotech, Inc. devices

FDA 510(k) Submission Details - K862007

510(k) Number K862007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1986
Decision Date July 01, 1986
Days to Decision 35 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
53d faster than avg
Panel avg: 88d · This submission: 35d
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 K862007.
CARDS(TM) HCG-URINE
K863199 · Pacific Biotech, Inc. · Sep 1986
TARGET HCG, ENZYME IMMUNOASSAY REAGENTS
K862247 · V-Tech, Inc. · Jul 1986
HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS
K862262 · Serono Diagnostics, Inc. · Jul 1986
BETA QUIK STICK
K860965 · Pacific Biotech, Inc. · Apr 1986
MEDIX VISUAL HCG - M HCG ENZYME IMMUNOASSAY
K860490 · Medix Biotech, Inc. · Mar 1986
TANDEM ICON II HCG IMMUNOENZYMETRIC ASSAY KIT
K860542 · Hybritech, Inc. · Mar 1986