Cleared Traditional

K833194 - TANDEM R-TOTAL B-GCG KIT

K833194 is an FDA 510(k) clearance for TANDEM R-TOTAL B-GCG KIT, manufactured by Hybritech, Inc.. The device is a Class 2 Chemistry device with product code JHI cleared through the Traditional 510(k) pathway after a 121-day FDA review.

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

FDA 510(k) Submission Details - K833194

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
Combination Product No
PCCP Authorized No
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.

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 K833194.
HCG RIA
K833851 · Syncor Intl. Corp. · Mar 1984
TANDEM VISUAL HCG IMMUNOENZYMETRIC
K834000 · Hybritech, Inc. · Feb 1984
STAR HCG MONOCLONAL ANTIBODY IMMUNORAD
K832796 · Syncor Intl. Corp. · Jan 1984
OREIA II B-HCG, ENZYME INNUNOASSAY
K832801 · Organon, Inc. · Dec 1983
MODIFIED CHORIO-SHURE
K832892 · Nuclear Medical Laboratories, Inc. · Oct 1983
BHCG RIA KIT
K831264 · Micromedic Systems · Jun 1983