(49 days)
Not Found
No
The document describes a quality control material for laboratory testing and does not mention any AI or ML components.
No
This device is a quality control material intended to monitor the precision of laboratory testing procedures, not to directly treat or diagnose a patient.
No
This device is a quality control material intended to monitor the precision of laboratory testing procedures, not to diagnose a condition in a patient.
No
The device description clearly states it is a "quality control serum" and "multi-analyte assayed QC materials," indicating it is a physical substance used for calibration and quality control in laboratory testing. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "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." This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes. While this specific device is a control material, it is an essential component used in IVD testing procedures.
- Device Description: The description mentions its use in "laboratory testing procedures" and as an "objective assessment of the precision of methods and techniques," which are core aspects of IVD testing.
- Performance Studies: The document details performance studies conducted on clinical chemistry and immunoassay systems (Abbott ARCHITECT c8000, ARCHITECT i2000, Beckman Coulter® AU480), which are common platforms for IVD testing. The studies evaluate aspects like value assignment and stability, which are crucial for ensuring the reliability of IVD results.
- Predicate Device: The mention of a predicate device (K043208; Liquid Assayed Multiqual®) which is also a quality control material, further supports its classification as an IVD component. Predicate devices are used to demonstrate substantial equivalence to a legally marketed device, and in this context, the predicate is also an IVD control.
While the device itself is a control material and not a test that directly diagnoses a condition, it is an integral part of the IVD testing process and is therefore considered an IVD device.
N/A
Intended Use / 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.
Product codes
JJY
Device Description
The use of quality control material is indicated as an objective assessment of the precision of methods and techniques and is an integral part of good laboratory practices. Three levels of control are available to allow performance monitoring within the analytical range. There is no difference in the formulation or manufacturing procedure between Multichem S Plus and Multichem S Plus (Assayed). Both are multi-analyte assayed QC materials with the same formula; however, there is a difference only in the product claims that are published to the users.
The following kit configurations are available:
Multichem S Plus (Assayed)
Model 05P78-10 with Level 1 control; 12 vials with 5 mL contents
Model 05P78-11 with Level 2 control; 12 vials with 5 mL contents
Model 05P78-12 with Level 3 control; 12 vials with 5 mL contents
Multichem S Plus
Model CH101PLA with Level 1 control; 15 vials with 10 mL contents
Model CH102PLA with Level 2 control; 15 vials with 10 mL contents
Model CH103PLA with Level 3 control; 15 vials with 10 mL contents
Each donor unit used in the preparation of the control material was tested by United States Food and Drug Administration (FDA) approved methods and found to be negative for antibodies to HIV and HCV, and non-reactive for HBsAg.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Value assignment testing was performed utilizing internal procedures and protocols to determine typical values that would be seen for the controls across Abbott ARCHITECT c8000 clinical chemistry and the ARCHITECT i2000 immunoassay systems with the associated reagent test systems. For the Multichem S Plus (Assayed) controls, 2 reagent fots and 2 calibrator lots were used where available to incorporate reagent and calibrator variation. 2 replicates from 16 runs were performed to give a total of 32 data points. Distinct runs, with minimum gaps of 2 hours were performed and a minimum of 8 calibration events were performed to incorporate variation from calibration and environmental sources. Value assignment ranges were established at the pre-determined criteria of 20% around the grand mean and expanded to 30% or as needed. However, a 10% range is applied to Potassium, Sodium and Chloride.
Stability studies have been performed to determine the open vial stability and shelf-life for this control. For open vial stability, Technopath utilized internal procedures and two protocol methods (Classical [Forward] method and Isochronous - Staggered Start [Back-ended] method) from CLSI EP25A entitled "Evaluation of Stability of In Vitro Diagnostic Reagents." To minimize variation, where possible, one lot of reagent, calibrator and reference/control was used for the entire study, per analyte. Testing was performed over multiple days on 1 Abbott ARCHITECT c8000 clinical chemistry system with the associated reagent test systems, with the exception of Rheumatoid Factor, which was tested on a Beckman Coulter® AU480 chemistry instrument. All Multichem S Plus (Assayed) analytes from open vial and freshly thawed vial samples were tested in replicates of 3 at each time points were tested and the point of failure was determined by the maximum allowable drift (degradation), which was determined to be analyte specific.
Open Vial Stability:
10 days at 2 to 8°C for each analyte with the following exceptions:
- 7 days at 2 to 8°C for Triglycerides
- 5 days at 2 to 8℃ for Lactate -
A combination of accelerated and preliminary real-time testing was carried out utilizing CLSI EP25A in order to support a shelf-life storage claim of -20° to -80°C for 30 months. The accelerated testing utilized three lots of controls and the real-time testing utilized a combination of two lots of controls. All data was generated using the Abbott ARCHITECT c8000 clinical chemistry system with the associated reagent test systems. For the Multichem S Plus (Assayed) controls, the Drift Limit was determined to be 10%. These results concluded that the Multichem S Plus / S Plus (Assayed) controls are predicted to be stable for in excess of 30 months when stored at -20℃ to - 80℃. The real-time testing is on-going.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
K132751
510(k) Summary Multichem S Plus / S Plus (Assayed) Control
1.0 Submitter:
Submitter Contact:
Paula McCarthy Head of Quality and Regulatory Affairs Technopath Fort Henry Business Park Ballina, Co. Tipperary Ireland Telephone: + 353 61 335844 Fax: + 353 61 203034 Email: paula.mccarthy@techno-path.com
Stephanie G. Garth Consultant Global Compliance Plus 325 Big Elm St. Highland Village, TX 75077 Telephone: 469-230-0959 Email: globalcomplianceplus@yahoo.com
2.0 Date Submitted:
August 28, 2013
OCT 2 2 2013
3.0 Device Identification
| Proprietary Names: | Multichem S Plus / S Plus (Assayed) |
|---|---|
| Common Name: | Multi-Analyte Controls, (Assayed and unassayed) |
| Classification: | Class 1, Reserved |
| Product Code: | JJY |
| Regulation Number: | 21 CFR 862.1660 |
: 4.0 Legally Marketed Predicate Device
| Candidate(s) . | «Predicate : | Manufacturer. | Document
- Number |
|----------------------|--------------------------------|---------------|----------------------|
| Multichem S Plus / S | Liquid Assayed Multiqual® | Bio-Rad | K043208 |
| Plus (Assayed) | (Model #s 694, 695, 696, 695X) | Laboratories | |
The Multichem S Plus (Assayed) control is substantially equivalent to the Bio-Rad product listed above, currently in commercial distribution.
Device Description 5.0
The use of quality control material is indicated as an objective assessment of the precision of methods and techniques and is an integral part of good laboratory practices. Three levels of control are available to allow performance monitoring within the analytical range. There is no difference in the formulation or manufacturing procedure between Multichem S Plus and Multichem S Plus (Assayed). Both are multi-analyte assayed QC materials with the same formula; however, there is a difference only in the product claims that are published to the users.
1
The following kit configurations are available:
Multichem S Plus (Assayed)
Model 05P78-10 with Level 1 control; 12 vials with 5 mL contents Model 05P78-11 with Level 2 control; 12 vials with 5 mL contents Model 05P78-12 with Level 3 control; 12 vials with 5 mL contents
Multichem S Plus
Model CH101PLA with Level 1 control; 15 vials with 10 mL contents Model CH102PLA with Level 2 control; 15 vials with 10 mL contents Model CH103PLA with Level 3 control; 15 vials with 10 mL contents
Each donor unit used in the preparation of the control material was tested by United States Food and Drug Administration (FDA) approved methods and found to be negative for antibodies to HIV and HCV, and non-reactive for HBsAg.
6.0 Intended 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 below in the table in section 7.0, in the package insert, and in the Indications for Use Form.
7.0 Comparison to the Predicate
Multichem S Plus / S Plus (Assayed) Plus control claims to be substantially equivalent to Liquid Assayed Multiqual . The controls have same/similar design and modes of operation. The key features are summarized in the following table.
| Characteristics | Predicate Device:
Liquid Assayed
Multiqual® | Proposed Device:
Multichem S Plus / S Plus (Assayed) Controls |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use: | Liquid Assayed
Multiqual is 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. | 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. |
| Form: | Liquid, Frozen | Liquid, Frozen |
| Matrix: | Human serum based | Human serum based |
| Storage
(Closed/Shelf-Life) | -20°C to -70°C Until
expiration date | -20°C to -80°C Until expiration date |
2
| Analytes | Multiqual® | Multichem S Plus | Multichem S Plus
(Assayed) |
|-------------------------|------------------------------------------|------------------------------------------|---------------------------------|
| Acetaminophen | Acetaminophen | Acetaminophen | Acetaminophen |
| Alpha-1 | | Alpha-1 | Alpha-1 |
| | | Acidglycoprotein | Acidglycoprotein |
| Alpha-1-Antitripsin | Alpha-1-Antitripsin
αHBDH | Alpha-1 Antitrypsin | Alpha-1 Antitrypsin |
| Apolipoprotein A-1 | Apolipoprotein A-1 | Apolipoprotein A1 | Apolipoprotein A1 |
| Apolipoprotein B | Apolipoprotein B | Apolipoprotein B | Apolipoprotein B |
| Alkaline Phosphatase | Alkaline Phosphatase
(ALP) | Alkaline Phosphatase | Alkaline Phosphatase |
| ALT/SGPT | ALT/SGPT | Alanine | Alanine |
| | | Aminotransferase | Aminotransferase |
| Amikacin | Amikacin | Amikacin | Amikacin |
| Amylase | Amylase | Amylase | Amylase |
| Amylase, Pancreatic | Amylase, Pancreatic
AST/SGOT | Amylase, Pancreatic | |
| | | Aspartate | Aspartate |
| | | Aminotransferase | Aminotransferase |
| Acid Phosphatase | Acid Phosphatase | Acid Phosphatase | |
| Albumin | Albumin | Albumin | Albumin |
| | | Beta-2 Microglobulin | Beta-2 Microglobulin |
| | | Bile acids | |
| Bilirubin, Direct | Bilirubin, Direct | Bilirubin, Direct | Bilirubin, Direct |
| Bilirubin, Neonatal | Bilirubin, Neonatal | | |
| Bilirubin, Total | Bilirubin, Total | Bilirubin, Total | Bilirubin, Total |
| C3 Complement | C3 Complement | Complement C3 | Complement C3 |
| C4 Complement | C4 Complement | Complement C4 | Complement C4 |
| Ceruloplasmin | Ceruloplasmin | Ceruloplasmin | Ceruloplasmin |
| Cholinesterase | Cholinesterase | Cholinesterase | |
| Calcium, Ionized | Calcium, Ionized | | |
| Copper | Copper | | |
| Calcium, Total | Calcium, Total | Calcium | Calcium |
| Carbamazepine | Carbamazepine | Carbamazepine | Carbamazepine |
| Carbon Dioxide (CO2) | Carbon Dioxide (CO2) | Carbon Dioxide
(Bicarbonate) | Carbon Dioxide
(Bicarbonate) |
| Chloride | Chloride | Chloride | Chloride |
| HDL | HDL | Cholesterol, HDL | Cholesterol, HDL |
| LDL | LDL | Cholesterol, LDL | Cholesterol, LDL |
| Cholesterol, Total | Cholesterol, Total | Cholesterol, Total | Cholesterol, Total |
| CK-MB Isoenzyme | CK-MB Isoenzyme | | |
| Cortisol | Cortisol | Cortisol | |
| Creatinine | Creatinine | Creatinine | Creatinine |
| Creatine Kinase (CK) | Creatine Kinase (CK) | Creatine Kinase | Creatine Kinase |
| | | C-Reactive Protein | C-Reactive Protein |
| Digoxin | Digoxin | | |
| | | Digoxin | Digoxin |
| Ferritin | Ferritin | | |
| Ethanol | Ethanol | Ethanol | Ethanol |
| GGT | Gamma
Glutamyltransferase | Gamma
Glutamyltransferase | |
| Gentamicin | Gentamicin | Gentamicin | |
| Globulin | Glucose | Glucose | |
| Glucose | Haptoglobin | Haptoglobin | |
| Haptoglobin | Iron | Iron | |
| Iron | Immunoglobulin A | Immunoglobulin A | |
| Immunoglobulin A (IgA) | Immunoglobulin G | Immunoglobulin G | |
| Immunoglobulin G (IgG) | Immunoglobulin M | Immunoglobulin M | |
| Immunoglobulin M (IgM) | TIBC | | |
| UIBC | Unsaturated Iron Binding Capacity (UIBC) | Unsaturated Iron Binding Capacity (UIBC) | |
| Lactate (Lactic Acid) | Lactate (Lactic acid) | Lactate (Lactic acid) | |
| LDH | Lactate Dehydrogenase | Lactate Dehydrogenase | |
| LAP Arylamidase | Lipase | Lipase | |
| Lipase | Lithium | Lithium | |
| Lithium | Magnesium | Magnesium | |
| Magnesium | Osmolality | | |
| Osmolality | Phenobarbital | Phenobarbital | |
| Phenobarbital | Phenytoin | | |
| Phenytoin | Phospholipids | | |
| Phospholipids | Phosphorus | Phosphorous | |
| Phosphorus | Potassium | Potassium | |
| Potassium | Prealbumin | Prealbumin | |
| Prealbumin | PAP | | |
| PAP | Protein Electrophoresis | | |
| Protein Electrophoresis | Protein, Total | Protein, Total | |
| Protein, Total | Rheumatoid Factor | Rheumatoid Factor | |
| Salicylate | Salicylate | Salicylate | |
| Sodium | Sodium | Sodium | |
| T3 Free | | | |
| T3 Total | | | |
| T3 Uptake/T-Uptake | | | |
| T4 total | Thyroxine (TT4) | | |
| T4 Free | | | |
| Theophylline | Theophylline | Theophylline | |
| TSH | | | |
| Tobramycin | Tobramycin | Tobramycin | |
| Transferrin | Transferrin | Transferrin | |
| Triglycerides | Triglycerides | Triglycerides | |
| Urea | | | |
| Urea Nitrogen (BUN) | Urea Nitrogen | Urea Nitrogen | |
| Uric Acid | Uric Acid | Uric Acid | |
:
. . . . .
5-3
3
:
5-4
.
4
| | Vitamin B12
Zinc | Vancomycin | Vancomycin |
|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|------------|
| Open Vial | 14 days at 2 to 8°C, with
the following exception:
Direct Bilirubin,
Triglycerides, HDL,
Cholinesterase and
Phosphorus for 7 days.
LAP Arylamidase will
be stable for 3 days. | 10 days at 2 to 8°C with the following exceptions:
Triglycerides will be stable for 7 days. Lactate will be
stable for 5 days. | |
- 8.0 Performance Characteristics
8.1 Value Assignment Summary
Value assignment testing was performed utilizing internal procedures and protocols to determine typical values that would be seen for the controls across Abbott ARCHITECT c8000 clinical chemistry and the ARCHITECT i2000 immunoassay systems with the associated reagent test systems. For the Multichem S Plus (Assayed) controls, 2 reagent fots and 2 calibrator lots were used where available to incorporate reagent and calibrator variation. 2 replicates from 16 runs were performed to give a total of 32 data points. Distinct runs, with minimum gaps of 2 hours were performed and a minimum of 8 calibration events were performed to incorporate variation from calibration and environmental sources. Value assignment ranges were established at the pre-determined criteria of 20% around the grand mean and expanded to 30% or as needed. However, a 10% range is applied to Potassium, Sodium and Chloride.
8.2 Stability Testing Summary
Stability studies have been performed to determine the open vial stability and shelf-life for this control. For open vial stability, Technopath utilized internal procedures and two protocol methods (Classical [Forward] method and Isochronous - Staggered Start [Back-ended] method) from CLSI EP25A entitled "Evaluation of Stability of In Vitro Diagnostic Reagents." To minimize variation, where possible, one lot of reagent, calibrator and reference/control was used for the entire study, per analyte. Testing was performed over multiple days on 1 Abbott ARCHITECT c8000 clinical chemistry system with the associated reagent test systems, with the exception of Rheumatoid Factor, which was tested on a Beckman Coulter® AU480 chemistry instrument. All Multichem S Plus (Assayed) analytes from open vial and freshly thawed vial samples were tested in replicates of 3 at each time points were tested and the point of failure was determined by the maximum allowable drift (degradation), which was determined to be analyte specific.
5
Open Vial Stability:
10 days at 2 to 8°C for each analyte with the following exceptions: �
- -7 days at 2 to 8°C for Triglycerides
- 5 days at 2 to 8℃ for Lactate -
A combination of accelerated and preliminary real-time testing was carried out utilizing CLSI EP25A in order to support a shelf-life storage claim of -20° to -80°C for 30 months. The accelerated testing utilized three lots of controls and the real-time testing utilized a combination of two lots of controls. All data was generated using the Abbott ARCHITECT c8000 clinical chemistry system with the associated reagent test systems. For the Multichem S Plus (Assayed) controls, the Drift Limit was determined to be 10%. These results concluded that the Multichem S Plus / S Plus (Assayed) controls are predicted to be stable for in excess of 30 months when stored at -20℃ to - 80℃. The real-time testing is on-going.
Note: ARCHITECT, c8000, and i2000 are trademarks of Abbott Laboratories.
8.3 Traceability Summary
The analytes contained within the Multichem S Plus (Assaved) controls were obtained from endogenous components to the base serum matrix and commercially available sources. Technopath does not claim traceability to higher order reference materials or methods.
9.0 Conclusion:
The conclusions drawn from the nonclinical tests (discussed above) demonstrate that the Multichem S Plus / S Plus (Assayed) control is as safe, as effective, and performs as well as the predicate device. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three wavy lines emanating from a central point. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 22, 2013
TECHNO-PATH MANUFACTURING LTD. c/o Stephanie G. Garth Global Compliance Plus 325 Big Elm Street HIGHLAND VILLAGE TX 75077
Re: K132751 Trade/Device Name: Multichem S Plus / S Plus (assayed) Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, reserved Product Code: JJY Dated: August 28, 2013 Received: September 3, 2013
Dear Ms. Garth:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
7
Page 2-Ms. Garth
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Carol Benson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
8
Indications for Use Form
K132751 510(k) Number (if known):
Device Name: Multichem S Plus / S Plus (Assayed)
Indications for Use:
Mukichem S Plus / S Plus (Assayed) control are intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures fisted in the package insert. Note: The following analytes are listed in the package insert:
Multichem S Plus
Acetaminophen Alpha-1 Acidglycoprotein Alpha-1 Antitrypsin Apolipoprotein A 1 Apolipoprotein B Alkaline Phosphatase Alanine Aminotransferase Amikacin Amylase Amylase, Pancreatic Aspartate Aminotransferase Acid Phosphatase Albumin Beta-2 Microglobulin Bile acids Bilirubin, Direct Bilirubin, Total Complement C3 Complement C4 Ceruloplasmin Cholinesterase Calcium
Multichem S Plus (Assayed)
Acetaminophen Alpha-1 Acidgly coprotein Alpha-1 Antitrypsin Apolipoprotein Al Apolipoprotein B Alkaline Alanine Aminotransferase Amikacin Amylase Aspartate Aminotransferase Albumin Beta-2 Microglobulin Bilirubin, Direct Bilirubin, Total Complement C3 Complement C4 Ceruloplasmin Calcium Carbamazenine Carbon Dioxide (Bicarbonate) Chloride
Prescription Use X Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Yung | [ 20 ] Chan - S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K132751 510(k)
Page 1 of 2
9
Multichem S Plus, cont'd
Carbamazepine Carbon Dioxide (Bicarbonate) Chloride Cholesterol, HDL Cholesterol, LDL Cholesterol, Total Cortisol Creatinine Creatine Kinase C-Reactive Protein Digoxin Ethanol Gamma Glutamyltransferase Gentamicin Glucose Haptoglobin Iron Immunoglobulin A Immunoglobulin G Immunoglobulin M Unsaturated Iron Binding Capacity (UIBC) Lactate (Lactic acid) Lactate Dehydrogenase Lipase Lithium Magnesium Phenobarbital Phenytoin Phosphorous Potassium Prealbumin Protein, Total Rheumatoid Factor Salicylate Sodium Thyroxine (TT4) Theophylline Tobramycin Transferrin Triglycerides Urea Nitrogen Uric Acid Valproic Acid
Multichem S Plus (Assayed), cont'd
Cholesterol. HDL Cholesterol, LDL Cholesterol. Total Creatinine Creatine Kinase C-Reactive Protein Digoxin Ethano) Gamma Glutamyltransferase Gentamicin Glucose Haptoglobin lron Immunoglobulin A Immunoglobulin G Immunoglobulin M Unsaturated Iron Binding Capacity (UIBC) Lactate (Lactic acid) Lactate Dehydrogenase Lipase Lithium Magnesium Phenobarbital Phosphorous Potassium Prealbumin Protein, Total Rheumatoid Factor Salicylate Sodium Theophylline Tobramycin Transferrin Triglycerides Urea Nitrogen Uric Acid Valproic Acid Vancomycin
Prescription Use X Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Yung YDC
Division Sian-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K132751
Vancomycin
. .