Cleared Traditional

K911881 - DSL BETA 2 MICROGLOBULIN (DSL 6200)

K911881 is the FDA 510(k) clearance for DSL BETA 2 MICROGLOBULIN (DSL 6200) by Diagnostic Systems Laboratories, Inc.. It is a Class 2 Microbiology device (product code JZG) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K911881 · Diagnostic Systems Laboratories, Inc. · Microbiology device
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Sep 1991
Decision
134d
Days
Class 2
Risk

K911881 is an FDA 510(k) clearance for the DSL BETA 2 MICROGLOBULIN (DSL 6200). Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Diagnostic Systems Laboratories, Inc. (Webster, US). The FDA issued a Cleared decision on September 10, 1991 after a review of 134 days - within the typical 510(k) review window.

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

View all Diagnostic Systems Laboratories, Inc. devices

Submission Details

510(k) Number K911881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1991
Decision Date September 10, 1991
Days to Decision 134 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 102d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Microbiology devices follow this clearance model.

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

All 41
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K911881.
DSL ACTIVE BETA2-MICROGLOBULIN (DSL 6500)
K915508 · Diagnostic Systems Laboratories, Inc. · Mar 1992
ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR
K914225 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1991
HUMAN BETA-2 MICROGLOBIN EN-RID KIT
K913131 · The Binding Site, Ltd. · Nov 1991
DSL BETA 2 MICROGLOBULIN (DSL 6100)
K912173 · Diagnostic Systems Laboratories, Inc. · Aug 1991
COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA
K912940 · Diagnostic Products Corp. · Jul 1991
NA ALPHA 1 MICROGLOBULIN KIT
K904254 · Behring Diagnostics, Inc. · Apr 1991