Sherlock Mycobacteria Identification System

K020689510(k) TraditionalCleared Oct 31, 2002241-day reviewClass I21 CFR 866.3370

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

Midi, Inc. · NJO System, Mycolic Acid Analysis, Mycobacterium Tuberculosis

Cleared on Oct 31, 2002 after a 241-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided: Oct 31, 2002
Review: 241 days
Class: Class I
Product code: NJO
Recalls: None
Predicates: 0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K020689Source: FDA 510(k) database · How lineage is built

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

Planning a device in NJO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

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.

How does its category compare?

All NJO devices

NJO System, Mycolic Acid Analysis, Mycobacterium Tuberculosis: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NJO

FDA has decided no NJO device since 2007.

Median 510(k) review, days · NJO

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

Recalls per year · NJO

No recall names NJO since 2007.

Adverse event reports per year · NJO

No MAUDE report names NJO since 2007.

View these four charts as a table

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

What is it indicated for?

Read the full statement (107 words)

The MIDI Sherlock@Mycobacteria Identification System is intended to aid in the identification of M.tuberculosis and differentiation from other mycobacteria species through the analysis of mycolic acids derived from cultured bacterial samples, using high performance liquid chromatography (HPLC) performed on the Agilent model 1100 HPLC, along with SherlockO pattern recognition software. The system is used, along with other identification methods, to identify mycobacteria that have been isolated from clinical specimens by traditional culturing techniques. Following observation of growth on the solid medium, identification of the mycobacterial isolate is done with the MIDI Sherlock@Mycobacteria Identification System device. Results should be interpreted in conjunction with other laboratory observations and procedures.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K020689 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020689: Sherlock Mycobacteria Identification System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020689

Report an extraction error

Are you the manufacturer?

Record history

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