510(k) · Cleared
ClearedMultichem IA and IA Plus
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 20, 2013 as substantially equivalent to K001373 (Bio-Rad, 2000) after a 74-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Sep 20, 2013
- Review
- 74 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001373 (2000). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K162530Multichem IA PlusTechno-Path Manufacturing · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001373 | Liquichek Immunoassay Plus Control, Model 360, 361, 362, 363 | Bio-Rad | 2000 | — |
| 0 (this device) | K132091 | Multichem IA and IA Plus | Techno-Path Manufacturing, Ltd. | 2013 | — |
| +1 | K162530 | Multichem IA Plus | Techno-Path Manufacturing | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
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 |
|---|---|---|---|
| * | K001373 | Liquichek Immunoassay Plus Control, Model 360, 361, 362, 363 | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162530 | Multichem IA Plus | 2017 | 0 |
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?
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 [A Plus is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analyxes listed in the package insert. The following analytes are listed in the package insert: Alpha Fetoprotein (APP) Folute Sex Hormone Binding Globulin Anti-thyroglobulin Prostate Specific Antigen, Fre T-Uptake Anti-thyroperoxidase Follicle Stimulating Hormone (ESH) Testosterone Human Chorionic Gonadotropin…
Read the full statement (130 words)
Multichem [A Plus is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analyxes listed in the package insert.
The following analytes are listed in the package insert:
Alpha Fetoprotein (APP) Folute Sex Hormone Binding Globulin
Anti-thyroglobulin Prostate Specific Antigen, Fre T-Uptake
Anti-thyroperoxidase Follicle Stimulating Hormone (ESH) Testosterone
Human Chorionic Gonadotropin (8KCG) Triiodothyronine, Free (FT3) Theophylline
BNP (1-32) Thyroxine, Free (P74) Troponin I
CA 125 Gentamicin Thyroid Stimulating Hormone (TSH)
CA 15-3 Homocysteinc Triiodothyronine, Total (M7)
CA 19-9 Immunoglobulin E Thyroxine, Total (174)
Carbamazepine Insulin Voiproic Acid
Carcinogenic Embryonic Antigen (CEA) Luteinizing Hormone Vancomycin
CK-MB Myoglobin Vitamin B12
Cortisol Parathyroid Hormone (PTI-) (1-84) 25-OH Vitamin D
C-Peplide Pbenobarbital
DHEA-Sul ratte Phenytoin
Digoxin Progesterone
Estradiol Prolactin
Ferritin Prostate Specific Antigen, Total
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132091 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132091: Multichem IA and IA Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132091
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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