510(k) · Cleared
Recalled · Class II · 2018MRSASelect II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Cleared on Dec 28, 2017 as substantially equivalent to K081212 (Bio-Rad, 2008) and 1 other predicate after a 262-day review. Its family tree reaches back 5 generations to 1986. It has been recalled once.
- Decided
- Dec 28, 2017
- Review
- 262 days
- Class
- Class II
- Product code
- JSO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K863821 (1986). No later device cites it as a predicate yet.
- Root · 5 generations backK863821 Mueller Hinton Agar W/4%Nacl and OxacillinGibco Laboratories Life Technologies, Inc. · 1986 · Recalled
- 4 generations backK042812 Bblchromagar MrsaBecton, Dickinson & CO · 2004
- 3 generations backK070361 MrsaselectBio-Rad · 2007
- 2 generations backK081212 Mrsaselect - Extended IncubationBio-Rad · 2008 · Recalled
- 1 generation backK100589 Mrsa Select - Skin and Soft Tissue Wound SpecimensBio-Rad · 2010
- This deviceK171061 MRSASelect IIBio-Rad · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K863821 | Mueller Hinton Agar W/4%Nacl and Oxacillin | Gibco Laboratories Life Technologies, Inc. | 1986 | 1 |
| −4 | K042812 | Bblchromagar Mrsa | Becton, Dickinson & CO | 2004 | — |
| −3 | K070361 | Mrsaselect | Bio-Rad | 2007 | — |
| −2 | K081212 | Mrsaselect - Extended Incubation | Bio-Rad | 2008 | 1 |
| −1 | K100589 | Mrsa Select - Skin and Soft Tissue Wound Specimens | Bio-Rad | 2010 | — |
| 0 (this device) | K171061 | MRSASelect II | Bio-Rad | 2017 | — |
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 JSO? 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
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K081212 | Mrsaselect - Extended IncubationSummary page 5…lin-susceptible staphylococci (MSS) are inhibited. Substantial Equivalency The MRSASelect™II is substantially equivalent to the Bio-Rad MRSASelect™ Extended Incubation (K081212) and MRSASelect™ Wound Specimen (K100589) products. Table 1 on the following page compares the characteristics of the Bio-Rad MRS… | 2008 |
| * | K100589 | Mrsa Select - Skin and Soft Tissue Wound SpecimensSummary page 5…nhibited. Substantial Equivalency The MRSASelect™II is substantially equivalent to the Bio-Rad MRSASelect™ Extended Incubation (K081212) and MRSASelect™ Wound Specimen (K100589) products. Table 1 on the following page compares the characteristics of the Bio-Rad MRSASelect™II (New Device) and the Bio-Rad M… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 8, 2018 | Class II | Z-1743-2019 | Nonconforming Material/Component | Abnormal coloration of agar plates and the growth of non-characteristic MRSA colonies. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 1 other device also cites its predicate K081212.
How does its category compare?
All JSO devicesJSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · JSO
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · JSO
262in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JSO
15in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JSO
513in 2025
MAUDE reports naming product code JSO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 2 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 1 | — | 4 | 0 |
| 2010 | 5 | 326 | 0 | 1 |
| 2011 | 2 | — | 3 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 32 |
| 2016 | 3 | 262 | 0 | 17 |
| 2017 | 2 | — | 2 | 43 |
| 2018 | 1 | — | 0 | 14 |
| 2019 | 1 | — | 0 | 9 |
| 2020 | 0 | — | 1 | 7 |
| 2021 | 0 | — | 0 | 27 |
| 2022 | 0 | — | 15 | 8 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 513 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
MRSASelect™II is a selective and differential chromogenic medium for: A) The qualitative detection of nasal colonization of methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test can be performed on anterior nares specimens from patients to screen for MRSA colonization. MRSASelect™II is not intended to diagnose MRSA infection nor to guide or monitor treatment of…
Read the full statement (192 words)
MRSASelect™II is a selective and differential chromogenic medium for:
A) The qualitative detection of nasal colonization of methicillin-resistant Staphylococcus aureus (MRSA) to aid in the prevention and control of MRSA infections in healthcare settings. The test can be performed on anterior nares specimens from patients to screen for MRSA colonization. MRSASelect™II is not intended to diagnose MRSA infection nor to guide or monitor treatment of infection. A negative result does not preclude MRSA nasal colonization. Concomitant cultures are necessary to recover organisms for identification, antimicrobial susceptibility testing, or epidemiological typing. Results can be interpreted after 18 to 28 hours incubation.
B) The qualitative detection of methicillin-resistant Staphylococcus aureus (MRSA) from skin and soft tissue wound specimens. The MRSASelect™II is indicated for use in conjunction with other laboratory tests and clinical data available to aid in the identification and diagnosis of MRSA from patients with skin and soft-tissue infections. Concomitant cultures and antimicrobial susceptibility testing are necessary for all skin and soft-tissue wound specimens. MRSASelect™II is not intended to guide, or monitor treatment for MRSA infection, or provide results of susceptibility to methicillin. Results can be interpreted after 18 to 28 hours incubation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171061: MRSASelect II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171061
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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