Cleared Traditional

HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP, HANDYLAB E3 EXTRACTION REAGENT, HANDYLAB (K090191) - FDA 510(k) Clearance

Class I Microbiology device.

K090191 · Handylab, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
485d
Days
Class 1
Risk

K090191 is an FDA 510(k) clearance for the HANDYLAB GBS ASSAY, HANDYLAB JAGUAR INSTRUMENT, HANDYLAB DNA EXTRACTION STRIP.... Classified as Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test (product code NJR), Class I - General Controls.

Submitted by Handylab, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on May 27, 2010 after a review of 485 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3740 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Handylab, Inc. devices

Submission Details

510(k) Number K090191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2009
Decision Date May 27, 2010
Days to Decision 485 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
383d slower than avg
Panel avg: 102d · This submission: 485d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3740
Definition A Nucleic Acid Amplification Assay System (including Probes, Other Reagents, And Instrumentation) Is An Aid In The Identification Of Group B Streptococci From Pre-partum And Intra-partum Women To Establish Colonization Status.
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 - NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test

All 17
Devices cleared under the same product code (NJR) and FDA review panel - the closest regulatory comparables to K090191.
Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
K222638 · Cepheid · Sep 2023
Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
K203429 · Cepheid · May 2022
Simplexa GBS Direct, Simplexa GBS Positive Control Pack
K182467 · Diasorin Molecular, LLC · Nov 2018
Panther Fusion GBS Assay
K181156 · Diagenode · Jul 2018
NeuMoDx GBS Assay
K173725 · Neumodx Molecular, Inc. · Jun 2018