510(k) Report

510(k) · Cleared

Cleared

Gamma Phage Lysis Assay for the Identification of Bacillus Anthrac

K143592510(k) SpecialCleared Apr 16, 2015119-day reviewClass II21 CFR 866.3045

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

The Surgeon General, Department of the Army · NVQ Bacteriophage And Controls, B. Anthracis Lysis

Cleared on Apr 16, 2015 as substantially equivalent to K051794 (Office of the Surgeon General, U.S. Army, 2005) after a 119-day review. Its family tree reaches back 1 generation to 2005.

Decided
Apr 16, 2015
Review
119 days
Class
Class II
Product code
NVQ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K051794 (2005). No later device cites it as a predicate yet.

K051794 · Gamma Phage Lysis Assay for the Identification of Bacillus Anthracis · Office of the Surgeon General, U.S. Army · 2005200620082010201220142016
K051794 · Gamma Phage Lysis Assay for the Identification of Bacillus Anthracis · Office of the Surgeon General, U.S. Army · 20050
  1. Root · 1 generation backK051794 Gamma Phage Lysis Assay for the Identification of Bacillus AnthracisOffice of the Surgeon General, U.S. Army · 2005
  2. This deviceK143592 Gamma Phage Lysis Assay for the Identification of Bacillus AnthracThe Surgeon General, Department of the Army · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K051794Gamma Phage Lysis Assay for the Identification of Bacillus AnthracisOffice of the Surgeon General, U.S. Army2005—
0 (this device)K143592Gamma Phage Lysis Assay for the Identification of Bacillus AnthracThe Surgeon General, Department of the Army2015—
FIG. 1 — Lineage of K143592, 2005–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K051794Gamma Phage Lysis Assay for the Identification of Bacillus Anthracis
Summary page 5
…Submission Type: Special 510k Device Class: Unclassified Product Code: NVQ Predicate Device: K051794 Gamma Phage Lysis for the Identification of Bacillus anthracis Indications for Use The Gamma…
Office of the Surgeon General, U.S. Army2005—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All NVQ devices

NVQ Bacteriophage And Controls, B. Anthracis Lysis: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · NVQ

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NVQ

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

Recalls per year · NVQ

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NVQ

No MAUDE report names NVQ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20151—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—10
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Gamma Phage assay is a lytic phage assay specific for Bacillus anthracis. The Gamma Phage assay (common name) can be used on suspect non-hemolytic, aerobic, gram-positive, “ground-glass”- appearing colonies from sheep blood agar in conjunction with other markers and testing for the identification of Bacillus anthracis. The assay is not intended for screening of blood or plasma donors.

Use of this assay is limited to designated laboratories within the Laboratory Response Network (LRN) and Department of Defense (D0D).

Indications for use as stated in the FDA summary.

More from The Surgeon General, Department of the…

2 FDA decisions under this applicant name. See the company

  • K140387Burn Resuscitation Decision Support System - Clinical (BRDSS-C)The Surgeon General, Department of the Army · 2014

Recent decisions in NVQ

The NVQ category page

  • K051794Gamma Phage Lysis Assay for the Identification of Bacillus AnthracisOffice of the Surgeon General, U.S. Army · 2005

https://510kreport.com/device/K143592 · printed Nov 5, 2026

Cite this page

510(k) Report. “K143592: Gamma Phage Lysis Assay for the Identification of Bacillus Anthrac.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143592

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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