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 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.

AI/ML Overview

This document is a 510(k) premarket notification for a quality control material (Multichem IA Plus), not an AI/ML medical device. Therefore, the information requested in your prompt regarding acceptance criteria and studies proving an AI/ML device meets them (e.g., sample size, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable or present in this document.

The document discusses the substantial equivalence of the "Multichem IA Plus" control to a previously marketed predicate device (K132091). The "study" referenced is primarily performance data related to product stability (open vial stability and shelf-life) for various analytes, which are typical for quality control materials in in-vitro diagnostics, not AI/ML algorithms.

Here's what can be extracted from the document relevant to its specific context:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present "acceptance criteria" for an AI/ML device's performance metrics like accuracy, sensitivity, or specificity. Instead, it details stability claims for a quality control material.

Acceptance Criteria (Product Claim)	Reported Device Performance (Stability Studies)
Open Vial Stability (at 2 to 8°C):	Achieved (based on claims stated by manufacturer)
- All analytes (general)	10 days
- C-Peptide, Homocysteine, Calcitonin & Troponin T	7 days
- PTH Intact, Troponin I & 25OH Vitamin D	4 days
- Folate	2 days
- ACTH	8 hours
- BNP	1 hour
Storage (Unopened)/Shelf-Life:	Achieved (based on claims stated by manufacturer)
- At -20° to -80°C	36 months

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated in terms of number of "samples" for each stability test. The document mentions "Stability studies have been performed," but does not quantify the number of batches or measurements.
Data Provenance: The studies were performed by the manufacturer, Technopath Manufacturing Ltd. No information about country of origin of the data beyond the manufacturer's location (Fort Henry Business Park, Ballina, Co. Tipperary, Ireland) is provided. These are laboratory studies for product stability, not clinical data sets.
Retrospective or Prospective: These would typically be prospective stability studies, where the product is tracked over time under specified conditions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This concept is not applicable to the type of device described. Ground truth for a quality control material's stability is established through analytical testing against known reference methods or specifications, not through expert consensus on images or clinical cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are relevant for subjective interpretations of data, typically in diagnostic imaging or clinical assessments, not for quantitative chemical measurements of control materials.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a laboratory quality control material, not a diagnostic imaging AI with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a reagent/control material, not an algorithm.

7. The type of ground truth used:

The "ground truth" for this device's performance (stability) would be based on:

Analytical Chemistry Measurements: Direct measurement of analyte concentrations over time using validated analytical methods.
Pre-defined Specifications: The manufacturer's internal specifications for acceptable recovery of analytes and stability limits.

8. The sample size for the training set:

Not applicable. As this is not an AI/ML device, there is no "training set."

9. How the ground truth for the training set was established:

Not applicable. No training set.

In summary, the provided document is a 510(k) for an in vitro diagnostic quality control material, not an AI/ML medical device. Therefore, the requested information regarding AI/ML device validation is not present. The "performance data" refers to the stability of the chemical control material.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

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 (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" (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 (800) 638-2041 or (301) 796-7100 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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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: bernd.hass@technopathcd.com

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	TechnopathManufacturing	K132091

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

5.0 Device Description

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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 intendedfor use as a quality controlserum to monitor the precisionof laboratory testing proceduresfor the analytes listed in thepackage insert.	Multichem IA Plus is intendedfor use as a quality controlserum to monitor the precisionof laboratory testing proceduresfor the analytes listed in thepackage insert.
Form:	Liquid, Frozen	Liquid, Frozen
Matrix:	Processed Human Serum	Processed Human Serum

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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(Unopened)Shelf Life	30 Months @ -20°C to -80°C	36 Months @ -20°C to -80°C
StorageOpen Vial	10 days, with the followingexceptions:BNP = 1 hourC-Peptide = 7 daysFolate = 2 daysHomocysteine = 7 daysPTH Intact = 4 daysTroponin I = 4 days25OH Vitamin D = 4 days	10 days, with the followingexceptions:BNP = 1 hourC-Peptide = 7 daysFolate = 2 daysHomocysteine = 7 daysPTH Intact = 4 daysTroponin I = 4 days25OH Vitamin D = 4 daysACTH = 8 hoursCalcitonin = 7 daysTroponin T = 7 days

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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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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.

Regulation Number and Section

§ 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.