MULTICHEM S PLUS / S PLUS (ASSAYED)

K132751 · Techno-Path Manufacturing , Ltd. · JJY · Oct 22, 2013 · Clinical Chemistry

Device Facts

• Record ID: K132751
• Device Name: MULTICHEM S PLUS / S PLUS (ASSAYED)
• Applicant: Techno-Path Manufacturing , Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Oct 22, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

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.

Device Story

Multichem S Plus / S Plus (Assayed) are multi-analyte quality control materials derived from human serum. They serve as an objective assessment tool for monitoring the precision of laboratory testing procedures. The device is provided in three levels to allow performance monitoring across the analytical range. It is used in clinical laboratory settings by laboratory professionals. The control material is processed alongside patient samples; healthcare providers compare the resulting values against established target ranges to verify the accuracy and precision of their analytical systems. This monitoring helps ensure the reliability of clinical test results, thereby supporting accurate patient diagnosis and management. The device is stored frozen (-20°C to -80°C) and is stable for up to 30 months.

Clinical Evidence

Bench testing only. Stability and value assignment studies were performed using the Abbott ARCHITECT c8000 and i2000 systems (and Beckman Coulter AU480 for Rheumatoid Factor). Value assignment used 32 data points per analyte (16 runs, 2 replicates). Stability was validated using CLSI EP25A protocols (Classical and Isochronous methods) to support 30-month shelf-life and analyte-specific open-vial stability (typically 10 days at 2-8°C).

Technological Characteristics

Human serum-based multi-analyte control. Provided as liquid, frozen. Storage: -20°C to -80°C. Analyte-specific open-vial stability (2-8°C). No traceability to higher-order reference materials claimed. Not software-driven; used as a reference standard in clinical chemistry/immunoassay analyzers.

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for specific analytes in clinical chemistry and immunoassay systems. Intended for professional laboratory use.

Regulatory Classification

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.

Predicate Devices

• Liquid Assayed Multiqual® (Model #s 694, 695, 696, 695X) (K043208)

Submission Summary (Full Text)

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# 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: [e-mail]

Stephanie G. Garth Consultant Global Compliance Plus 325 Big Elm St. Highland Village, TX 75077 Telephone: [phone] Email: [e-mail]

#### 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<br>- 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.

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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:<br>Liquid Assayed<br>Multiqual® | Proposed Device:<br>Multichem S Plus / S Plus (Assayed) Controls |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use: | Liquid Assayed<br>Multiqual is intended for<br>use as an assayed quality<br>control serum to monitor<br>the precision of<br>laboratory testing<br>procedures for the<br>analytes listed in the<br>package insert. | Multichem S Plus / S Plus (Assayed) control are<br>intended for use as an assayed quality control serum<br>to monitor the precision of laboratory testing<br>procedures for the analytes listed in the package<br>insert. |
| Form: | Liquid, Frozen | Liquid, Frozen |
| Matrix: | Human serum based | Human serum based |
| Storage<br>(Closed/Shelf-Life) | -20°C to -70°C Until<br>expiration date | -20°C to -80°C Until expiration date |

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| Analytes | Multiqual® | Multichem S Plus | Multichem S Plus<br>(Assayed) |
|-------------------------|------------------------------------------|------------------------------------------|---------------------------------|
| Acetaminophen | Acetaminophen | Acetaminophen | Acetaminophen |
| Alpha-1 | | Alpha-1 | Alpha-1 |
| | | Acidglycoprotein | Acidglycoprotein |
| Alpha-1-Antitripsin | Alpha-1-Antitripsin<br>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<br>(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<br>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<br>(Bicarbonate) | Carbon Dioxide<br>(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<br>Glutamyltransferase | Gamma<br>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

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:

5-4

.

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| | Vitamin B12<br>Zinc | Vancomycin | Vancomycin |
|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|------------|
| Open Vial | 14 days at 2 to 8°C, with<br>the following exception:<br>Direct Bilirubin,<br>Triglycerides, HDL,<br>Cholinesterase and<br>Phosphorus for 7 days.<br>LAP Arylamidase will<br>be stable for 3 days. | 10 days at 2 to 8°C with the following exceptions:<br>Triglycerides will be stable for 7 days. Lactate will be<br>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.

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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.

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## 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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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

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## 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

. .