510(k) · Cleared
ClearedMultichem P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Techno-Path Manufacturing, Ltd. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Sep 25, 2013 as substantially equivalent to K022991 (Bio-Rad, 2002) after an 89-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Sep 25, 2013
- Review
- 89 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011494 (2001). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011494 | Liquichek Immunology Control Level 1,2,3,1, ML, Liquichek Immunology Control… | Bio-Rad | 2001 | — |
| −1 | K022991 | Liquichek Immunology Control Level 1, 2, and 3-1 ML, Model 591, 592, 593… | Bio-Rad | 2002 | — |
| 0 (this device) | K131992 | Multichem P | 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 JJY? 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 |
|---|---|---|---|
| * | K022991 | Liquichek Immunology Control Level 1, 2, and 3-1 ML, Model 591, 592, 593; Level 1, 2…Summary page 1…Number Multichem P Liquichek Immunology Bio-Rad K022991 Control Laboratories I The Multichemn P Control is substantiall… | 2002 |
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 12 years and passes through 2 companies; a new generation was cleared every 11.0 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K022991.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Multichem P is intended for use as a single level assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
The following analytes are listed in the package insert:
Alpha- I Acidglycoprotein
Alpha-I Antitiypsin
Apolipoprotein Al (APO Al)
Apolipoprotein B (APO B)
Beta-2 Microglobulin-
Ceruloplasmin
Complement C3
Complement C4
C-Reactive Protein
Haptoglobin
Immunoglobulin A
Immunoglobulin G
Immunoglobulin M
Prealbumnin
Rheumatoid Factor (1(F)
Transferrin
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K131992 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131992: Multichem P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131992
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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