Cleared Traditional

K972638 - TINA-QUANT PREALBUMIN

K972638 is an FDA 510(k) clearance for TINA-QUANT PREALBUMIN, manufactured by Boehringer Mannheim Corp.. The device is a Class 1 Immunology device with product code JZJ cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K972638 · Boehringer Mannheim Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
178d
Days
Class 1
Risk

K972638 is an FDA 510(k) clearance for the TINA-QUANT PREALBUMIN. Classified as Prealbumin, Antigen, Antiserum, Control (product code JZJ), Class I - General Controls.

Submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on January 9, 1998 after a review of 178 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5060 - 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 - K972638

510(k) Number K972638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1997
Decision Date January 09, 1998
Days to Decision 178 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
74d slower than avg
Panel avg: 104d · This submission: 178d
Pathway characteristics
Predicate-based equivalence.

JZJ Device Classification - Class 1, General Controls

Product Code JZJ Prealbumin, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5060
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JZJ Prealbumin, Antigen, Antiserum, Control

All 8
Devices cleared under the same product code (JZJ) and FDA review panel - the closest regulatory comparables to K972638.
RANDOX PREALBUMIN
K000661 · Randox Laboratories, Ltd. · Apr 2000
HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT
K951966 · Kent Laboratories, Inc. · Jun 1995
PREALBUMIN IMMUNOLOGICAL NL TEST KIT
K913672 · The Binding Site, Ltd. · Dec 1991
QM300 PREALBUMIN ANTIBODY PACK
K883002 · Kallestad Diag, A Div. of Erbamont, Inc. · Sep 1988
ANTISERUM TO HUMAN PREALBUMIN
K850686 · Kent Laboratories, Inc. · Nov 1985
LASER PREALBUMIN TEST
K851912 · Behring Diagnostics, Inc. · Jun 1985