# K132751: Multichem S Plus / S Plus (Assayed)

- Pathway: 510(k) (Abbreviated)
- Applicant: Techno-Path Manufacturing, Ltd.
- Decided: Oct 22, 2013 after 49 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K923633 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043208: Liquid Assayed Multiqual Control, Bio-Rad (2005) Summary page 1.

## Recalls of this device
- Apr 9, 2019 · Class III · Z-1362-2019: Devices were delivered without the required dry ice.
- Apr 9, 2019 · Class III · Z-1363-2019: Devices were delivered without the required dry ice.

## Indications for use
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

Source page: https://510kreport.com/device/K132751
Methodology: https://510kreport.com/methodology