510(k) · Cleared

Recalled · Class I · 2020

Simplexa HSV 1&2 Direct/Positive Control Pack

K141458510(k) SpecialCleared Jul 1, 201429-day reviewClass II21 CFR 866.3307Recalls 2 (1 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Focus Diagnostics · PGH Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel

Cleared on Jul 1, 2014 as substantially equivalent to DEN130049 (Focus Diagnostics, 2014) after a 29-day review. Its family tree reaches back 1 generation to 2014. 1 of the 2 devices in its family, counting itself, has a Class I recall. It has been recalled 2 times, including a Class I recall.

Decided: Jul 1, 2014
Review: 29 days
Class: Class II
Product code: PGH
Recalls: 2 (1 Class I)
Predicates: 1

Its longest line of descent runs back 1 generation to DEN130049 (2014). No later device cites it as a predicate yet. 1 of the 2 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backDEN130049 Simplexa HSV 1&2 DirectFocus Diagnostics · 2014
This deviceK141458 Simplexa HSV 1&2 Direct/Positive Control PackFocus Diagnostics · 2014

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	DEN130049	Simplexa HSV 1&2 Direct	Focus Diagnostics	2014	—
0 (this device)	K141458	Simplexa HSV 1&2 Direct/Positive Control Pack	Focus Diagnostics	2014	—

FIG. 1 — Lineage of K141458, 2014–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new PGH device

#1 K250050 miDiagnostics HSV-1&2 CSF Testscore 10.1 · 1 generation · no Class I recall

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	DEN130049	Simplexa HSV 1&2 Direct Our reading of the summary gave K133621, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN130049, Simplexa HSV 1&2 Direct (Focus Diagnostics), granted Mar 21, 2014; older De Novo requests were first filed under a 510(k) number, so this links to the grant.	Focus Diagnostics	2014	—

Also cleared against DEN130049: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 12, 2020	Class II	Z-2547-2020	Under Investigation by firm	Due to a software malfunction in the Multi Assay Suite, there is the probability of increased occurrence of false negative results.
Feb 10, 2016	Class I	Z-1272-2016	Under Investigation by firm	Focus Diagnostics is recalling the Direct Amplification Discs (DAD) supplied with the Simplexa HSV 1 & 2 Direct (MOL2150), Simplexa Flu A/B & RSV Direct (MOL2650) and Simplexa Group A Strep Direct kits (MOL2850) because it may result in a…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
1 other device also cites its predicate DEN130049.

How does its category compare?

All PGH devices

PGH Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · PGH

1in 2025

2007high 2 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PGH

Too few PGH 510(k)s in any year since 2007 to give a median.

Recalls per year · PGH

No recall names PGH since 2007.

Adverse event reports per year · PGH

No MAUDE report names PGH since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	2	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	1	—	0
2026	0	—	—

What is it indicated for?

The Focus Diagnostics SimplexaTM HSV I & 2 Direct is intended for use on the 3M Integrated Cycler instrument for the qualitative detection and differentiation of HSV- I and HSV-2 DNA in cerebrospinal fluid (CSF) samples from patients suspected of herpes simplex virus (HSV) infections of the central nervous system (CNS). This test is intended as an aid in the diagnosis of HSV-l and HSV-2 infections of the CNS. Negative results do not preclude HSV- I or…

Read the full statement (152 words)

Negative results do not preclude HSV- I or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions.

The assay is not intended for use as a donor screening test. The assay is for professional use only.

The SimplexaTM HSV I & 2 Positive Control Pack is intended to be used as a control with the SimplexaTM HSV I & 2 Direct kit. This control is not intended for use with other assays or systems.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K141458 · printed Nov 6, 2026

Cite this page

510(k) Report. “K141458: Simplexa HSV 1&2 Direct/Positive Control Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141458

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026