FDA product code KTN: System, Test, Infectious Mononucleosis
KTN is the FDA product code for system, test, infectious mononucleosis. It is a Class II device, regulated under 21 CFR 866.5640 and reviewed by the Microbiology panel. FDA has cleared 59 510(k) submissions under KTN, from 45 different applicants. The average 510(k) review took 70 days (median 41). FDA has posted 9 recalls for KTN devices.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Infectious Mononucleosis |
| Device class | Class II |
| Regulation | 21 CFR 866.5640 |
| Review panel | MI — Microbiology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for KTN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 21 |
Compare with all 510(k) review times · Search every KTN clearance
Top KTN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| J.S. Medical Assoc. | 3 | 1993-09-08 |
| Ampcor, Inc. | 3 | 1992-07-14 |
| Armkel, LLC | 3 | 1990-02-26 |
| Texas Immunology, Inc. | 3 | 1989-01-23 |
| Instrumentation Laboratory CO | 2 | 2003-02-24 |
40 more applicants have KTN clearances. See the full list in Caduvo.
Most recent KTN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K181436 | SEKISUI Diagnostics, LLC | OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test | 2018-06-22 | 21 |
| K042272 | ACON Laboratories, Inc. | ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) | 2005-02-28 | 189 |
| K030215 | Instrumentation Laboratory CO | BIORAPID MONONUCLEOSIS | 2003-02-24 | 34 |
| K012901 | Instrumentation Laboratory CO | COLOR-MONOGEN | 2001-09-27 | 29 |
| K982634 | Oxoid , Ltd. | DRYSPOT INFECTIOUS MONONUCLEOSIS KIT | 1999-01-28 | 184 |
Recalls for KTN devices
9 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-06-22.
Frequently asked questions
What is FDA product code KTN?
KTN is the FDA product code for system, test, infectious mononucleosis. It is a Class II device, regulated under 21 CFR 866.5640 and reviewed by the Microbiology panel.
What device class is KTN?
Class II, regulation 21 CFR 866.5640. Typical premarket route: 510(k).
How long does a 510(k) take for product code KTN?
Across 59 cleared submissions the average was 70 days from receipt to decision (median 41).
Which companies have the most KTN clearances?
J.S. Medical Assoc. (3); Ampcor, Inc. (3); Armkel, LLC (3); Texas Immunology, Inc. (3); Instrumentation Laboratory CO (2).
Have KTN devices been recalled?
Yes: 9 product recalls across 3 recall events; the most recent began 2016-06-22.
Next steps
- Run an FDA pathway report with predicate devices for product code KTN
- Run a recall and safety report across every KTN manufacturer
- Watch product code KTN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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