Cleared Traditional

K980724 - TINAQUANT B 2-MICROGLOBULIN ASSAY

K980724 is an FDA 510(k) clearance for TINAQUANT B 2-MICROGLOBULIN ASSAY, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Immunology device with product code JZG cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K980724 · Boehringer Mannheim Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
234d
Days
Class 2
Risk

K980724 is an FDA 510(k) clearance for the TINAQUANT B 2-MICROGLOBULIN ASSAY. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Pleasanton, US). The FDA issued a Cleared decision on October 16, 1998 after a review of 234 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5630 - the FDA immunology device 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K980724

510(k) Number K980724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1998
Decision Date October 16, 1998
Days to Decision 234 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 104d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JZG Device Classification - Class 2, Special Controls

Product Code JZG System, Test, Beta-2-microglobulin Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5630
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 Immunology devices follow this clearance model.

Regulatory Peers - JZG System, Test, Beta-2-microglobulin Immunological

All 42
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K980724.
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