Multichem IA Plus

K162530 · Techno-Path Manufacturing · JJY · Mar 31, 2017 · Clinical Chemistry

Device Facts

• Record ID: K162530
• Device Name: Multichem IA Plus
• Applicant: Techno-Path Manufacturing
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 31, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

For In Vitro Diagnostic use only. Multichem IA Plus is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Device Story

Multichem IA Plus is a liquid, frozen quality control serum used in clinical laboratories to monitor the precision of diagnostic testing procedures. It is prepared from human serum supplemented with purified biochemical materials (human/animal origin), chemicals, drugs, stabilizers, and preservatives. The device is provided in three levels to allow performance monitoring across the clinical range. Laboratory technicians use the control by running it alongside patient samples; the resulting values are compared against expected ranges to verify the accuracy and precision of the testing system. This objective assessment helps ensure the reliability of clinical diagnostic results, ultimately supporting accurate patient diagnosis and treatment monitoring. Each donor unit is screened for HIV, HCV, and HBsAg.

Clinical Evidence

No clinical data. Bench testing only. Stability testing (shelf-life and open-vial) performed per CLSI EP25-A. Value assignment conducted using 15 replicates per analyte across multiple runs to establish target means and 3SD ranges.

Technological Characteristics

Quality control material composed of processed human serum with added biochemicals, drugs, stabilizers, and preservatives. Provided in liquid, frozen form. Shelf life: 36 months at -20°C to -80°C. Open-vial stability varies by analyte (1 hour to 10 days at 2-8°C). No electronic components, software, or energy sources.

Indications for Use

Indicated for use as a quality control serum to monitor the precision of laboratory testing procedures for specific analytes in clinical settings. Prescription use only.

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

• Multichem IA Plus (k132091)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 31, 2017

TECHNO-PATH MANUFACTURING BERND HASS HEAD OF QUALITY AND REGULATORY AFFAIRS FORT HENRY BUSINESS PARK BALLINA, CO. TIPPERARY IRELAND

Re: K162530

Trade/Device Name: Multichem IA Plus Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I. Reserved Product Code: JJY Dated: March 3, 2017 Received: March 3, 2017

Dear Bernd Hass:

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.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

**Kellie B. Kelm -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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) k162530

Device Name Multichem IA Plus

Indications for Use (Describe)

For In Vitro Diagnostic use only.

Multichem IA Plus is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

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Image /page/3/Picture/0 description: The image shows a logo for TECHNOPATH. The logo features a stylized DNA double helix in shades of blue above the company name. The text "TECHNOPATH" is written in a sans-serif font with wide spacing between the letters.

# 510(k) Summary Multichem IA Plus assayed Control

# 1.0 Submitter:

Bernd Hass Head of Quality and Regulatory Affairs Techno-path Manufacturing Ltd Fort Henry Business Park Ballina, Co. Tipperary Ireland Telephone: + 353 61 525700 Email: [e-mail]

# 2.0 Date Sumbitted:

31st March 2017

# 3.0 Device Identification

Submission Type: Abbreviated 510(k) Abbreviated 510(k) number: k162530 Basis: Device Modification Device Name: Multi-Analyte Controls, All Kinds (Assayed) Trade Name: Multichem IA Plus Model Number: IA300 A, 05P76-10 (IA310A, IA311A, IA312A, IA313A)

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Classification Regulation: CFR 862.1660

Class: Class I, reserved

Panel: Clinical Chemistry

Generic Category: Quality Control Material (Assayed and Unassayed)

Product Code: JJY

# 4.0 Legally Marketed Predicate Device

| Candidate | Predicate | Manufacturer | Document number |
|-------------------|-------------------|-----------------------------|-----------------|
| Multichem IA Plus | Multichem IA Plus | Technopath<br>Manufacturing | K132091 |

The Multichem IA Plus control is substantially equivalent to the predicate, product listed above, currently in commercial distribution.

# 5.0 Device Description

The Multichem IA Plus control is prepared from human serum to which purified biochemical material (extracts of human and animal origin), chemicals, drugs, preservatives and stabilizers have been added. The control is used in liquid form for convenience.

The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practices. Three levels of control are available to allow performance monitoring within the clinical range.

Multichem IA Plus controls are prepared from human serum with added constituents of human and animal origin, chemicals, therapeutic drugs, stabilizers and preservatives. The control is provided in liquid form for convenience.

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.

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The following kit configurations are available:

Multichem IA Plus

Model IA310A (Trilevel) with Level 1, 2 & 3 control; 12 vials with 5 mL contents

Model 05P56-10 (Trilevel) with Level 1, 2 & 3 control; 12 vials with 5 mL contents

Model IA311A with Level 1 control; 12 vials with 5 mL contents

Model IA312A with Level 2 control; 12 vials with 5 mL contents

Model IA313A with Level 3 control; 12 vials with 5 mL contents

# 6.0 Intended Use

For In Vitro Diagnostic use only.

Multichem IA Plus is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

# 7.0 Comparison to the Predicate

Multichem IA Plus Control has been updated since the original 510k submission. The key features are summarized in the following table:

| Characteristics | Predicate Device: | Proposed Device: |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Multichem IA Plus Assayed | Multichem IA Plus Assayed |
| | Control k132091 | Control |
| Similarities | | |
| Intended Use: | Multichem IA Plus is intended<br>for use as a quality control<br>serum to monitor the precision<br>of laboratory testing procedures<br>for the analytes listed in the<br>package insert. | Multichem IA Plus is intended<br>for use as a quality control<br>serum to monitor the precision<br>of laboratory testing procedures<br>for the analytes listed in the<br>package insert. |
| Form: | Liquid, Frozen | Liquid, Frozen |
| Matrix: | Processed Human Serum | Processed Human Serum |

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Image /page/6/Picture/0 description: The image shows a logo with a stylized DNA double helix above the word "TECHNOPATH". The DNA helix is rendered in shades of blue, with a lighter blue strand intertwined with a darker blue strand. The word "TECHNOPATH" is written in a simple, sans-serif font, with each letter separated by a space.

| Changes / Differences | | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Analytes (Assigned) | Alpha Fetoprotein | Alpha Fetoprotein |
| | BNP | BNP |
| | CA 125 | CA 125 |
| | CA 15-3 | CA 15-3 |
| | CA 19-9 | CA 19-9 |
| | Carbamazepine | Carbamazepine |
| | Carcinogenic Embryonic Antigen | Carcinogenic Embryonic Antigen |
| | CK-MB | CK-MB |
| | Cortisol | Cortisol |
| | C-Peptide | C-Peptide |
| | DHEA Sulfate | DHEA Sulfate |
| | Digoxin | Digoxin |
| | Estradiol | Estradiol |
| | Ferritin | Ferritin |
| | Folate | Folate |
| | Follicle Stimulating Hormone | Follicle Stimulating Hormone |
| | Gentamicin | Gentamicin |
| | Homocysteine | Homocysteine |
| | Human Chorionic Gonadotropin | Human Chorionic Gonadotropin |
| | Insulin | Insulin |
| | Leutinizing Hormone | Leutinizing Hormone |
| | Myoglobin | Myoglobin |
| | Phenobarbital | Phenobarbital |
| | Phenytoin | Phenytoin |
| | Progesterone | Progesterone |
| | Prolactin | Prolactin |
| | Prostate Specific Antigen, Total | Prostate Specific Antigen, Total |
| | PTH Intact | PTH Intact |
| | Testosterone | Testosterone |
| | Theophylline | Theophylline |
| | Thyroid Stimulating Hormone | Thyroid Stimulating Hormone |
| | Thyroxine, Free (free T4) | Thyroxine, Free (free T4) |
| | Triiodothyronine, Free (free T3) | Triiodothyronine, Free (free T3) |
| | Troponin I | Troponin I |
| | Valproic Acid | Valproic Acid |
| | Vancomycin | Vancomycin |
| | Vitamin B12 | Vitamin B12 |
| | Anti - TPO | Anti - TPO |
| | Anti-thyroglobulin | Anti-thyroglobulin |
| | SHBG | SHBG |
| | PSA (free) | PSA (free) |
| | T Uptake | T Uptake |
| | T3 (total) | T3 (total) |
| | T4 (total) | T4 (total) |
| | 25OH Vitamin D | 25OH Vitamin D |
| | IgE | IgE |
| | - | Acetaminophen |
| | - | ACTH |
| | - | Amikacin |
| | - | Calcitonin |
| | - | Human Growth Hormone |
| | - | Lithium |
| | - | Salicylate |
| | - | Thyroglobulin |
| | - | Tobramycin |
| | - | Estriol, Free |
| | - | EPO |
| | - | NT Pro BNP |
| | - | Troponin T |
| Storage<br>(Unopened)<br>Shelf Life | 30 Months @ -20°C to -80°C | 36 Months @ -20°C to -80°C |
| Storage<br>Open Vial | 10 days, with the following<br>exceptions:<br>BNP = 1 hour<br>C-Peptide = 7 days<br>Folate = 2 days<br>Homocysteine = 7 days<br>PTH Intact = 4 days<br>Troponin I = 4 days<br>25OH Vitamin D = 4 days | 10 days, with the following<br>exceptions:<br>BNP = 1 hour<br>C-Peptide = 7 days<br>Folate = 2 days<br>Homocysteine = 7 days<br>PTH Intact = 4 days<br>Troponin I = 4 days<br>25OH Vitamin D = 4 days<br>ACTH = 8 hours<br>Calcitonin = 7 days<br>Troponin T = 7 days |

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Image /page/7/Picture/0 description: The image shows a logo with a stylized DNA double helix in blue. The helix is curved and symmetrical, with a lighter shade of blue used for the inner strands. Below the helix, there is text that appears to be part of the logo, but it is not fully visible in the image. The overall design is clean and modern, suggesting a connection to science, technology, or genetics.

# 8.0 Summary of Performance Data

A number of changes have been introduced for the Technopath Multichem IA Plus Control as outlined above. The differences have been tested to ensure that they do not present any new safety or effectiveness concerns. Stability studies have been performed to determine the open vial stability and shelf life for this control.

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Image /page/8/Picture/0 description: The image shows a logo for a company called TECHNOPATH. The logo features a stylized DNA helix in shades of blue above the company name. The helix is symmetrical, with the two strands curving towards each other in the center. The company name is written in a simple, sans-serif font.

# Product claims are as follows:

# Open Vial Stability:

- 10 days at 2 to 8℃ for all analytes with the following exceptions ●
- 7 days at 2 to 8°C = C-Peptide, Homocysteine, Calcitonin & Troponin T. ●
- 4 days at 2 to 8°C = PTH Intact, Troponin I & 250H Vitamin D
- 2 days at 2 to 8°C = Folate .
- 8 hours at 2 to 8°C = ACTH ●
- 1 hour at 2 to 8°C = BNP

# Storage (Unopened)/Shelf-Life:

- 36 months at -20° to -80°C
In conclusion, that data and the submission provide the summary data necessary to demonstrate substantially equivalent to the referenced predicate already in commercial distribution. Additional supporting data is retained on file at Techno-path Manufacturing, Ltd. The summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.