Cleared Traditional

TANDEM R-TOTAL B-GCG KIT (K833194) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K833194 · Hybritech, Inc. · Chemistry device
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Jan 1984
Decision
121d
Days
Class 2
Risk

K833194 is an FDA 510(k) clearance for the TANDEM R-TOTAL B-GCG KIT. Classified as Visual, Pregnancy Hcg, Prescription Use (product code JHI), Class II - Special Controls.

Submitted by Hybritech, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 18, 1984 after a review of 121 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 Hybritech, Inc. devices

Submission Details

510(k) Number K833194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1983
Decision Date January 18, 1984
Days to Decision 121 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 88d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K833194.
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
SAS BLOOD/SERUM/URINE/URINE HCG
K022683 · Sa Scientific, Inc. · Dec 2002
SAS VALUE HCG
K020438 · Sa Scientific, Inc. · Mar 2002