510(k) Report

510(k) · Cleared

Cleared

Amplicor CT/NG Test for Chlamydia Trachomatis; Roche Scripts for CT/NG Test Accessory

K070174510(k) TraditionalCleared Apr 16, 200788-day reviewClass I21 CFR 866.3120

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

Roche Diagnostics Corporation · MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia

Cleared on Apr 16, 2007 as substantially equivalent to K973707 (Roche Molecular Systems, Inc., 1999) after an 88-day review. Its family tree reaches back 1 generation to 1999.

Decided
Apr 16, 2007
Review
88 days
Class
Class I
Product code
MKZ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K973707 (1999). No later device cites it as a predicate yet.

K973707 · Roche Amplicor CT/NG Test for Chlamydia Trachomatis · Roche Molecular Systems, Inc. · 1999 · recalled1996199820002002200420062008
K973707 · Roche Amplicor CT/NG Test for Chlamydia Trachomatis · Roche Molecular Systems, Inc. · 1999 · recalled0
  1. Root · 1 generation backK973707 Roche Amplicor CT/NG Test for Chlamydia TrachomatisRoche Molecular Systems, Inc. · 1999 · Recalled
  2. This deviceK070174 Amplicor CT/NG Test for Chlamydia Trachomatis; Roche Scripts for…Roche Diagnostics Corporation · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K973707Roche Amplicor CT/NG Test for Chlamydia TrachomatisRoche Molecular Systems, Inc.19991
0 (this device)K070174Amplicor CT/NG Test for Chlamydia Trachomatis; Roche Scripts for CT/NG Test…Roche Diagnostics Corporation2007—
FIG. 1 — Lineage of K070174, 1999–2007Source: 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.

Planning a device in MKZ? 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 MKZ device

  1. #1 K230451 Aptima® Chlamydia trachomatis Assayscore 6.3 · 1 generation · no Class I recall
Get a 510(k) Report

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
*K973707Roche Amplicor CT/NG Test for Chlamydia Trachomatis
Summary page 2
…test for Neisseria gonorrhoeae Predicate We claim equivalence to the currently marketed AMPLICOR CT/NG test for Device Chlamydia trachomatis cleared under K973707. Comparison - The table below shows the similarities between the AMPLICOR CT/NG test similarities for Chlamydia trachomatis…
Roche Molecular Systems, Inc.19991

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 a recall.

How does its category compare?

All MKZ devices

MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · MKZ

1in 2023

2007: 22008: 22009: 22012: 12014: 12023: 1
2007high 2 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MKZ

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

Recalls per year · MKZ

1in 2010

2009: 12010: 1
2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · MKZ

1in 2025

2010: 12011: 92012: 12013: 62014: 22015: 12016: 12017: 62018: 32019: 32020: 72021: 92022: 22023: 42024: 72025: 1
2007high 9 (2011) · low 0 (2007)2025

MAUDE reports naming product code MKZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
20082—00
20092—10
20100—11
20110—09
20121—01
20130—06
20141—02
20150—01
20160—01
20170—06
20180—03
20190—03
20200—07
20210—09
20220—02
20231—04
20240—07
20250—01
20260—0—

What is it indicated for?

The AMPLICOR CT/NG test for Chlamydia trachomatisis a qualitative in vitro test for the detection of C. trachomatis DNA in urine from symptomatic or asymptomatic males, in endocervical swab specimens from symptomatic or asymptomatic females, and in urethral swab specimens from symptomatic males as evidence infection with C. trachomatis. C. trachomatisDNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization…

Read the full statement (168 words)

The AMPLICOR CT/NG test for Chlamydia trachomatisis a qualitative in vitro test for the detection of C. trachomatis DNA in urine from symptomatic or asymptomatic males, in endocervical swab specimens from symptomatic or asymptomatic females, and in urethral swab specimens from symptomatic males as evidence infection with C. trachomatis. C. trachomatisDNA is detected by Polymerase Chain Reaction (PCR) amplification of target DNA and by hybridization capture of amplified target.

Sample and control preparation can either be accomplished manually or automated using the optional Roche Scripts for AMPLICOR CT/NG Test accessory to direct the Tecan Genesis RSP 150 workstation. Urine specimens are not indicated for use with the automated sample preparation option.

The Roche Scripts for AMPLICOR CT/NG Test are intended to provide software scripts to direct the automated Tecan Genesis RSP 150 workstation to process swab samples or control material for analysis using either of the following four 510(k)-cleared assay test systems:

* AMPLICOR ® CT/NG test for Chlamydia trachomatis

* AMPLICOR ® CT/NG test for Neisseria gonorrhoeae

Indications for use as stated in the FDA summary.

More from Roche Diagnostics Corporation

6 FDA decisions under this applicant name. See the company

  • K141929Accu-Chek Connect Diabetes Management AppRoche Diagnostics Corporation · 20151 recall
  • K142089Accu-Chek Aviva Expert SystemRoche Diagnostics Corporation · 2014
  • K133862Accu-Chek Aviva Plus SystemRoche Diagnostics Corporation · 20142 recalls
  • K112528Elecsys T4 Calcheck 5Roche Diagnostics Corporation · 2011
  • K070172Amplicor CT/NG Test for Neisseria GonorrhoeaeRoche Diagnostics Corporation · 2007

Recent decisions in MKZ

The MKZ category page

  • K230451Aptima® Chlamydia trachomatis AssayHologic, Inc. · 2023
  • K140446BD Probetec Chlamydia Trachomatis (CT) QX Amplified Dna AssayBecton, Dickinson & CO · 2014
  • K110923Cobas 4800 CT / NG TestRoche Molecular Systems, Inc. · 20122 recalls
  • K091724BD Probetec Chlamydia Trachomatis (CT) Q Amplified Dna AssayBecton, Dickinson & CO · 2009
  • K090824BD Probetec Chlamydia Trachomatis (CT) QX Amplified Dna AssayBecton, Dickinson & CO · 2009

https://510kreport.com/device/K070174 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070174: Amplicor CT/NG Test for Chlamydia Trachomatis; Roche Scripts for CT/NG Test Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070174

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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