Cleared Special

HCG STAT PAK ULTRA-FAST (K011550) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K011550 · Chembio Diagnostic Systems, Inc. · Chemistry device
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Aug 2001
Decision
88d
Days
Class 2
Risk

K011550 is an FDA 510(k) clearance for the HCG STAT PAK ULTRA-FAST. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Chembio Diagnostic Systems, Inc. (Beverly, US). The FDA issued a Cleared decision on August 14, 2001 after a review of 88 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Chembio Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K011550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2001
Decision Date August 14, 2001
Days to Decision 88 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 88d · This submission: 88d
Pathway characteristics
Modification to existing cleared device.

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 374
Devices cleared under the same product code (JHI) and FDA review panel - the closest regulatory comparables to K011550.
Innovita HCG Pregnancy Rapid Combo Test
K241919 · Innovita (Tangshan) Biological Technology Co., Ltd. · Aug 2024
Alltest Pregnancy Rapid Combo Test Cassette
K203272 · Hangzhou AllTest Biotech Co., Ltd. · Jan 2022
Atellica IM Total hCG (ThCG)
K172322 · Siemens Healthcare Diagnostics, Inc. · Mar 2018
ACCESS TOTAL BHCG
K023480 · Beckman Coulter, Inc. · Dec 2002
ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
K980173 · Beckman Instruments, Inc. · Mar 1998
ABBOTT TESTPACK PLUS HCG COMBO WITH OBC
K965116 · Abbott Laboratories · Feb 1997