(48 days)
Not Found
No
The summary describes a quality control material for laboratory testing and does not mention any AI or ML components. The performance studies focus on stability testing, not algorithmic performance.
No.
This device is a quality control material used to monitor the precision of laboratory testing procedures for HbA1c, not for treating any medical condition.
No
This device is a quality control material used to monitor the precision of laboratory testing procedures for HbA1c. It is not used to diagnose a patient's condition.
No
The device description clearly states it is a quality control material prepared from human red blood cells with added chemicals and stabilizers, provided in liquid form. This indicates a physical, biological product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring the precision of laboratory testing procedures for the analyte, HbA1c". This is a key characteristic of an IVD, as it's used in vitro (outside the body) to assess the performance of diagnostic tests.
- Device Description: It describes the material as a "quality control material" used for "objective assessment of the precision of methods and techniques in use". Quality control materials are a type of IVD used to ensure the accuracy and reliability of diagnostic tests.
- Analyte: It specifically mentions monitoring the precision of testing for "HbA1c", which is a clinically relevant analyte measured in diagnostic tests.
- User/Setting: It's intended for "laboratory testing procedures", which is the typical setting for IVD use.
While it's not a diagnostic test itself that provides a patient result, it is a crucial component used with diagnostic tests to ensure their quality and accuracy. This function falls squarely under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Multichem A1c control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analyte, HbA1c, as listed in the package insert.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
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. A minimum of two levels of control are available to allow performance monitoring within the clinical range of HbA1c assay method. Multichem A1c control is prepared from human red blood cells with added chemicals and stabilizers. The control is provided in liquid form for convenience.
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
Not Found
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)
Stability studies have been performed to determine the open vial stability and shelf life for this control.
Product claims are as follows:
Open vial stability: 30 days at 2°C to 8°C
Storage (Closed/Shelf-Life): -20°C to -80°C until expiration date.
Open Vial testing was performed (at 2°C -8°C) by testing vials which were thawed and opened for pre-defined durations (test vials) against a freshly thawed, unopened vial (reference vials). All analytes from open vial and freshly thawed vial samples were tested in replicates of 3 at each time-point.
Acceptance criteria: Maximum Allowable Degradation / Drift Limit
§ 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.
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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 an abstract symbol that resembles a stylized human figure in profile, with three overlapping faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
TECHNOPATH MANUFACTURING BERND HASS HEAD OF QUALITY AND REGULATORY AFFAIRS FORT HENRY BUSINESS PARK BALLINA CO. TIPPERARY, IRELAND
October 26, 2016
Re: K162514
Trade/Device Name: Multichem A1c Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, Reserved Product Code: JJX Dated: September 5, 2016 Received: September 26, 2016
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.
1
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/Resourcesfor You/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.
Katherine Serrano -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) | K162514 |
| Device Name | Multichem Alc |
| Indications for Use (Describe) | Multichem Alc control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analyte, HbA1c, as 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) |
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| PSC Publishing Services (301) 443-6740 EF |
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510(k) Summary Multichem A1c (Assayed) Control
1.0 Submitter:
Bernd Hass Head of Quality and Regulatory Affairs Technopath Manufacturing Ltd. Fort Henry Business Park Ballina, Co. Tipperary Ireland Telephone: + 353 61 525700 Email: bernd.hass@technopathcd.com
2.0 Date Sumbitted:
26st October 2016
3.0 Device Identification
Proprietary Names: Multichem A1c Common Name: Quality Control material, single (specified) analytes Classification: Class 1, Reserved Product Code: JJX Regulation Number: 21 CFR 862.1660
4.0 Legally Marketed Predicate Device
| Candidate | Predicate | Manufacturer | Document number |
|---|---|---|---|
| Multichem A1c | CONE-TROL | ||
| Hemoglobin A1c | |||
| Control set | Cone Bioproducts | K121534 |
The Multichem A1c control is substantially equivalent to the Cone Bio product listed above, currently in commercial distribution.
5.0 Device Description
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. A minimum of two levels of control are available to allow performance monitoring within the clinical range of HbA1c assay method. Multichem A1c control is prepared from human red blood cells with added chemicals and stabilizers. The control is provided in liquid form for convenience.
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The following kit configurations are available: Multichem A1c Model HB000A (bi-level) with Level 1 & 2 control; 12 vials with 1 mL contents Model HB001A with Level 1 control; 12 vials with 1 mL contents Model HB002A with Level 2 control; 12 vials with 1 mL contents Model HB000M (bi-level minipak) with Level 1 & 2 control; 1 vial with 1 mL contents Model HB000T (bi-level) with Level 1 & 2 control; 12 vials with 1 mL contents Model HB001T with Level 1 control; 12 vials with 1 mL contents Model HB002T with Level 2 control; 12 vials with 1 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 A1c control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analyte, HbA1c as listed in the package insert.
7.0 Comparison to the Predicate
Multichem A1c control claims to be substantially equivalent to CONE-TROL Hemoglobin A1c control set. The controls have same/similar design and modes of operation. The key features are summarized in the following table.
| Characteristics | Predicate Device:
CONE-TROL Hemoglobin A1c
Control Set | Proposed Device:
Multichem A1c |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | CONE-TROL Hemoglobin A1c
Control Set is intended for
use as a quality control
material to monitor the
performance and precision
of Hemoglobin A1c
determination methods. | Multichem A1c control is
intended for use as an
assayed quality control
material to monitor the
precision of laboratory
testing procedures for the
analyte, HbA1c as listed in
the package insert. |
| Analytes | A1c | A1c |
| Form: | Liquid | Liquid |
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| Matrix: | Human Blood, Stabilisers, and preservatives | Human Blood and Stabilisers, and preservatives |
|---|---|---|
| Storage | -20°C | -20°C to -80°C |
| Thawed and Open | Open Vial Stability (2°C -8°C) | |
| 180 days | Open Vial Stability (2°C -8°C) | |
| 30 days | ||
| Shelf Life | 2 years | 1 years (12 mth) |
8.0 Value assignment process
The value assignment performance outlined here, was performed using a single analyser with single reagent and calibrator lot. Variability was introduced by performing the testing over multiple days.
Target assigned here were performed on the, Tosoh, Beckman and Trinity analysers, independently, with values claimed on each platform. The control target is the mean value of all the replicates generated on the specified instrument. The number of replicates performed is detailed in the below tables. No data points were excluded. Target values assigned have to be with the following acceptance specifications:
LEVEL 1
| Acceptance Ranges | ||||
|---|---|---|---|---|
| ANALYTES | Analyser Reported Units | TARGET | LOW | HIGH |
| % HbA1c | (DCCT/NGSP) | 5.50 | 4.00 | 7.00 |
| A1c | IFCC mmol/mol | 36.6 | 20.2 | 53.0 |
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| Acceptance Ranges | ||||
|---|---|---|---|---|
| ANALYTES | Analyser Reported Units | TARGET | LOW | HIGH |
| % HbA1c | (DCCT/NGSP) | 10.5 | 8.00 | 13.0 |
| A1c | IFCC mmol/mol | 91.3 | 63.9 | 119 |
The control ranges are set based on a review of the imprecision (3 x Standard Deviation) of the (instrument specific) value assignment data with a minimum applied range of ±10%.
Lot A0004150
Tosoh - Value Assignment testing was performed over 5 days with n = 45 replicates
| Hemoglobin A1c | % | Unit | Level 1 | Level 2 | ||
|---|---|---|---|---|---|---|
| Range | Target | Range | Target | Range | ||
| Tosoh | ||||||
| (G8) | 10% | NGSP (%) | ||||
| mmol/mol | 5.97 | |||||
| 41.8 | 5.37 - 6.57 | |||||
| 35.2 - 48.3 | 10.2 | |||||
| 87.6 | 9.18 - 11.2 | |||||
| 76.8 - 98.9 |
Beckman - Value Assignment testing was performed over 5 days with n = 23 replicates
| Hemoglobin A1c | %
Range | Unit | Level 1 | | Level 2 | |
|----------------------|------------|----------------------|---------|-------------|---------|-------------|
| | | | Target | Range | Target | Range |
| Beckman
(AU 5800) | 25% | NGSP (%)
mmol/mol | 5.35 | 4.01 - 6.69 | 9.91 | 7.43 - 12.4 |
| | | | 35.0 | 20.3 - 49.6 | 84.9 | 57.7 - 112 |
Trinity Biotech - Value Assignment testing was performed over 5 days with n = 15 replicates
| Hemoglobin A1c | %
Range | Unit | Level 1 | | Level 2 | |
|----------------------------------------|------------|----------------------|--------------|----------------------------|--------------|---------------------------|
| | | | Target | Range | Target | Range |
| Trinity Biotech
Premier
(Hb9210) | 10% | NGSP (%)
mmol/mol | 5.02
31.4 | 4.52 - 5.52
25.9 - 36.8 | 10.5
91.5 | 9.47 - 11.6
80.0 - 103 |
LEVEL 2
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9.0 Summary of Performance Data
Stability studies have been performed to determine the open vial stability and shelf life for this control. Product claims are as follows:
Open vial stability: 30 days at 2°C to 8°C Storage (Closed/Shelf-Life): -20°C to -80°C until expiration date.
The submission provides the summary data necessary to demonstrate substantial equivalence to the reference predicate. 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.
Stability (Open Vial)
The Multichem A1c (Assayed) controls were evaluated using an Isochronous (Staggered Start [Backwards / Back-ended]) protocol design as per CLSI EP25-A.
Open Vial testing was performed (at 2°C -8°C) by testing vials which were thawed and opened for pre-defined durations (test vials) against a freshly thawed, unopened vial (reference vials). All analytes from open vial and freshly thawed vial samples were tested in replicates of 3 at each time-point.
Acceptance criteria: Maximum Allowable Degradation / Drift Limit