Cleared Traditional

K990553 - IGM FLEX REAGENT CARTRIDGE

K990553 is the FDA 510(k) clearance for IGM FLEX REAGENT CARTRIDGE by Dade Behring, Inc.. It is a Class 2 Immunology device (product code CFQ) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K990553 · Dade Behring, Inc. · Immunology device

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Mar 1999

Decision

28d

Days

Class 2

Risk

K990553 is an FDA 510(k) clearance for the IGM FLEX REAGENT CARTRIDGE. Classified as Radioimmunoassay, Immunoglobulins (g, A, M) (product code CFQ), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on March 22, 1999 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number	K990553 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 22, 1999
Decision Date	March 22, 1999
Days to Decision	28 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

76d faster than avg

Panel avg: 104d · This submission: 28d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	CFQ Radioimmunoassay, Immunoglobulins (g, A, M)
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 866.5510

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 - CFQ Radioimmunoassay, Immunoglobulins (g, A, M)

All 10

Devices cleared under the same product code (CFQ) and FDA review panel - the closest regulatory comparables to K990553.

IGA MININEPH ANTISERUM

K981786 · The Binding Site, Ltd. · Nov 1999

IGG FLEX REAGENT CARTRIDGE

K990551 · Dade Behring, Inc. · Mar 1999

IMMUNOGLOBULIN A TEST SYSTEM

K990552 · Dade Behring, Inc. · Mar 1999

OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT

K951013 · Olympus America, Inc. · Apr 1995

OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT

K951055 · Olympus America, Inc. · Apr 1995

OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT

K950900 · Olympus America, Inc. · Mar 1995

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K990553

Dade Behring, Inc.

Newark, DE · US

CATHY P CRAFT

Regulatory profile

343 submissions 343 cleared

100% clearance rate · Active in Immunology

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