510(k) · Cleared
ClearedMultichem WBT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techno-Path Manufacturing, Ltd. · DIF Drug Mixture Control Materials
Cleared on Sep 20, 2013 as substantially equivalent to K072721 (Bio-Rad, Diagnostics Grp., 2007) after a 67-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Sep 20, 2013
- Review
- 67 days
- Class
- Class I
- Product code
- DIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K895905 (1990). No later device cites it as a predicate yet.
- Root · 4 generations backK895905 Lyphochek Whole Blood Control (Human) Levels 1,2,3Bio-Rad · 1990
- 3 generations backK980871 Lyphochek Whole Blood ControlBio-Rad · 1998
- 2 generations backK022041 Lyphochek Whole Blood Control, Models 561, 562, 563Bio-Rad Laboratories, Inc. · 2002
- 1 generation backK072721 Lyphochek Whole Blood Immunosuppressant Control , Abbott…Bio-Rad, Diagnostics Grp. · 2007
- This deviceK132174 Multichem WBTTechno-Path Manufacturing, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K895905 | Lyphochek Whole Blood Control (Human) Levels 1,2,3 | Bio-Rad | 1990 | — |
| −3 | K980871 | Lyphochek Whole Blood Control | Bio-Rad | 1998 | — |
| −2 | K022041 | Lyphochek Whole Blood Control, Models 561, 562, 563 | Bio-Rad Laboratories, Inc. | 2002 | — |
| −1 | K072721 | Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCC | Bio-Rad, Diagnostics Grp. | 2007 | — |
| 0 (this device) | K132174 | Multichem WBT | Techno-Path Manufacturing, Ltd. | 2013 | — |
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 DIF? 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072721 | Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCCSummary page 1…__ __ Number Multichemn WBT Lyphocheck® Whole Bic-Rad K072721 Blood Immunosuppressant Laboratories… | 2007 |
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?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K072721.
How does its category compare?
All DIF devicesDIF Drug Mixture Control Materials: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DIF
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DIF
35in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIF
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIF
1in 2016
MAUDE reports naming product code DIF, 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 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 3 | 35 | 0 | 3 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 5 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Multichemn WET control is intended for use as an assayed quality control
material to monitor the precision of laboratory testing procedures for the analytes
listed in the package insert. The Multichemn WBT control consists of 3 different
levels of control solutions prepared from human whole blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132174 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132174: Multichem WBT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132174
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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