510(k) · Cleared
Recalled · Class III · 2019Multichem S Plus / S Plus (Assayed)
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 Oct 22, 2013 as substantially equivalent to K043208 (Bio-Rad, 2005) after a 49-day review. Its family tree reaches back 3 generations to 1992. It has been recalled 2 times.
- Decided
- Oct 22, 2013
- Review
- 49 days
- Class
- Class I
- Product code
- JJY
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K923633 (1992). No later device cites it as a predicate yet.
- Root · 3 generations backK923633 Multiqual Assay ProductsCiba Corning Diagnostics Corp. · 1992
- 2 generations backK011867 Liquid Assayed Multiqual Control LEVEL1 #981600; Level 2 #981700…Bio-Rad · 2001
- 1 generation backK043208 Liquid Assayed Multiqual ControlBio-Rad · 2005
- This deviceK132751 Multichem S Plus / S Plus (Assayed)Techno-Path Manufacturing, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923633 | Multiqual Assay Products | Ciba Corning Diagnostics Corp. | 1992 | — |
| −2 | K011867 | Liquid Assayed Multiqual Control LEVEL1 #981600; Level 2 #981700; Level 3… | Bio-Rad | 2001 | — |
| −1 | K043208 | Liquid Assayed Multiqual Control | Bio-Rad | 2005 | — |
| 0 (this device) | K132751 | Multichem S Plus / S Plus (Assayed) | 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 |
|---|---|---|---|
| * | K043208 | Liquid Assayed Multiqual ControlSummary page 1…< j rredicite, KManufsicturir. t Documnent Multichem S Plus /S Liquid Assayed Multiqua Bio-Rad K043208 Plus (Assayed) (Model 4s 694, 695, 696, 695X) Laboratories The Multichem S Plus IS Plus (Assayed) co… | 2005 |
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 |
|---|---|---|---|---|
| Apr 9, 2019 | Class III | Z-1362-2019 | Under Investigation by firm | Devices were delivered without the required dry ice. |
| Apr 9, 2019 | Class III | Z-1363-2019 | Under Investigation by firm | Devices were delivered without the required dry ice. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K043208.
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 S Plus / S Plus (Assayed) control are intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. Note: The following analytes are listed in the package insert: Multichem S Plus Multichem S Plus (Assayed) Acetaminophen Acetaminophen Alpha-I Acidglycoprotein Alpha-I Acidglycoprotein Alpha-I Antitrypsin Alpha-I Antitrypsin Apolipoprotein Al…
Read the full statement (258 words)
Multichem S Plus / S Plus (Assayed) control are intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. Note: The following analytes are listed in the package insert:
Multichem S Plus Multichem S Plus (Assayed)
Acetaminophen Acetaminophen
Alpha-I Acidglycoprotein Alpha-I Acidglycoprotein
Alpha-I Antitrypsin Alpha-I Antitrypsin
Apolipoprotein Al Apolipoprotein AlI
Apolipoprotein Bl Apolipoproteiri B
Alkaline Phosphatase Alkaline Alanine Aminotransferase
Alanine Aminotransferase Amikacin
Amikacin Amylase
Amylase Aspartate Aminotransferase
Amylase. Pancreatic Albumin
Aspartate Aminotransferase Beta-2 Microglobulin
Acid Phosphatase Bilirubin. Direct
Albumin Bilirubin, Total
Beta-2 Microglobulin Complement C3
Bile acids Complement C4
Bilirubin, Direct Ceruloplasmin
Bilirubin, Total Calcium
Complement C3 Carbamazepine
Complement C4 Carbon Dioxide (Bicarbonate)
Ceruloplasmin Chloride
Cholinesterase
Calcium
Multichem S Plus. cont'd Multichem S Plus (Assayed), cont'd
Carbamazepine Cholesterol. HDL
Carbon Dioxide (Bicarbonate) Cholesterol, LDL
Chloride Cholesterol. Total
Cholesterol, HDL Creatinine
Cholesterol, LDL Creatine Kinase
Cholesterol, Total C-Reactive Protein
Cortisol Digoxin
Creatinine Ethanol
Creatine Kinase Gamma Glutamyltransferase
C-Reactive Protein Gentamicin
Digoxin Glucose
Ethanol Haptoglobin
Gamma Glutamyltransferase Iron
Gentamicin Immunoglobulin A
Glucose Immunoglobulin G
Haptoglobin Immunoglobulin M
Iron Unsaturated Iron Binding Capacity (UIBC)
Immunoglobulin A Lactate (Lactic acid)
Immunoglobulin G Lactate Dehydrogenase
Immunoglobulin M Lipase
Unsaturated Iron Binding Capacity (UIBC) Lithium
Lactate (Lactic acid) Magnesium
Lactate Dehydrogenase Phenobarbital
Lipase Phosphorous
Lithium Potassium
Magnesium Prealbumin
Phenobarbital Protein, Total
Phenytoin Rheumatoid Factor
Phosphorous Salicylate
Potassium Sodium
Prealbumin Theophylline
Protein, Total Tobramycin
Rheumatoid Factor Transferrin
Salicylate Triglycerides
Sodium Urea Nitrogen
Thyroxine (TT4) Uric Acid
Theophylline Valproic Acid
Tobramycin Vancomycin
Transferrin
Triglycerides
Urea Nitrogen
Uric Acid
Valproic Acid
Vancomycin
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132751 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132751: Multichem S Plus / S Plus (Assayed).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132751
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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