(496 days)
Multichem ID-G: Multichem ID-G is intended for use as a qualitative positive quality control serum to monitor the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG and Anti-HIV 1 IgG detected by Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer's recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
Multichem ID-GNeg: Multichem ID-GNeg is intended for use as a qualitative negative quality control serum to monitor the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG and Anti-HIV 1 IgG detected by the Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer's recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
Multichem ID-G and Multichem ID-GNeg are each supplied as single level controls. These products are prepared from human plasma. Multichem ID-G contains Hepatitis B Surface Antigen (HBsAg), and lgG antibodies to HIV-1 (Human Immunodeficiency Virus Type 1), HCV (Hepatitis C Virus), HBc (Hepatitis B Core Antigen) and Treponema pallidum. Multichem ID-GNeg does not contain analytes for HBsAg, anti-HIV-1 lgG, anti-HCV lgG, anti-HBc lgG, and anti-Treponema pallidum lgG. These controls are provided in liquid form for convenience. Each control is available as either 1 or 4 vials x 4 ml/vial.
Multichem ID-G is manufactured by adding the required analytes to the negative delipidated human serum base matrix, described above. Human disease state plasma that has tested positive for the required analyte using an FDA-cleared/approved assay is used to spike the base matrix to each target specification and within the ranges set for the Roche Immunoassay systems (Tables 1 and 2).
N/A
FDA 510(k) Clearance Letter - K242492
Page 1
December 30, 2025
Techno-Path Manufacturing, Ltd.
Alan Mcdonagh
RA Specialist
Fort Henry Business Park,
Ballina
Co. Tipperary, V94 FF1P
Ireland
Re: K242492
Trade/Device Name: Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)
Regulation Number: 21 CFR 866.3920
Regulation Name: Assayed Quality Control Material For Clinical Microbiology Assays
Regulatory Class: Class II
Product Code: QCH
Dated: December 30, 2025
Received: December 4, 2025
Dear Alan McDonagh:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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K242492 - Alan Mcdonagh Page 2
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
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K242492 - Alan Mcdonagh Page 3
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Uwe Scherf -S
Uwe Scherf, M.Sc., Ph.D.
Director
Division of Microbiology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K242492
Device Name
Multichem ID-G, Multichem ID-GNeg
Indications for Use (Describe)
Multichem ID-G: Multichem ID-G is intended for use as a qualitative positive quality control serum to monitor the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG and Anti-HIV 1 IgG detected by Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer's recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
Multichem ID-GNeg: Multichem ID-GNeg is intended for use as a qualitative negative quality control serum to monitor the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG and Anti-HIV 1 IgG detected by Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer's recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Page 5
510(k) SUMMARY
Date of Summary: December 30, 2025
Product Name: Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)
Sponsor: Techno-path Manufacturing, Ltd.
Correspondent: Alan McDonagh
RA Specialist
Fort Henry Business Park,
Ballina, Tipperary,
Ireland
Telephone: +353 (0) 61 525700
Email: technopath.regulatoryaffairs@lgcgroup.com
Common Name: Assayed quality control material for clinical microbiology assays.
Regulation Number: 21 CFR 866.3920
Classification: Class II
Product Code(s): QCH
Predicate Device: PreciControl Anti-HAV II [K190428]
Substantial Equivalency:
| Device & Predicate Device(s): | K190428 | K242492 |
|---|---|---|
| Device Trade Name | PreciControl Anti-HAV II | Multichem ID-G/Multichem ID-GNeg |
| General Device Characteristic Similarities | ||
| Intended Use/Indications For Use | PreciControl Anti-HAV II is used for quality control of the Elecsys Anti-HAV II immunoassay on cobas e immunoassay analyzers. | Multichem ID-G is intended for use as a qualitative positive quality control serum to monitor the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG, and Anti-HIV 1 IgG detected by the Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer's recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements. |
Page 6
| Multichem ID-GNeg is intended for use as a qualitative negative quality control serum to monitor the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG, and Anti-HIV 1 IgG detected by the Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer's recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements. | ||
|---|---|---|
| Summary | PreciControl Anti‑HAV II is a ready‑for‑use control serum based on human serum both in the negative and positive concentration range. The controls are used for monitoring the performance of the Elecsys Anti‑HAV II immunoassay. | Multichem ID-GNeg/Multichem ID-G is designed for and intended to be used solely with the procedures and immunoassays indicated in the Instructions for Use. These products are not intended to replace manufacturer's recommended controls provided in their package insert. |
General Device Characteristic Differences
| K190428 | K242492 | |
|---|---|---|
| Form: | Liquid | Liquid |
| Matrix: | Human blood | Human blood |
| Storage: | 2–8°C | 2–8°C |
| Open Vial Stability: | 8 weeks at 2–8°C | 30 days at 2–8°C |
| Shelf Life: | 15 months at 2–8°C | Multichem ID-G: 11 months at 2–8°CMultichem ID-GNeg: 11 months at 2–8 °C |
| Analyte(s): | Antibodies against hepatitis A virus (HAV) | anti-HIV-1 IgG, anti-HBc IgG, anti-HCV, IgG HBsAg, anti-Treponema pallidum IgG |
Intended Use
Multichem ID-G is intended for use as a qualitative positive quality control serum to monitor the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG, and Anti-HIV 1 IgG detected by the Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer's recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
Multichem ID-GNeg is intended for use as a qualitative negative quality control serum to monitor
Page 7
the precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG, and Anti-HIV 1 IgG detected by the Roche cobas heterogeneous immunoassay systems. These products are not intended to replace manufacturer's recommended controls provided in their package insert. Quality Control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.
Test Principle
Not applicable; this is control material to monitor performance of a test.
Device Description
Multichem ID-G and Multichem ID-GNeg are each supplied as single level controls. These products are prepared from human plasma. Multichem ID-G contains Hepatitis B Surface Antigen (HBsAg), and lgG antibodies to HIV-1 (Human Immunodeficiency Virus Type 1), HCV (Hepatitis C Virus), HBc (Hepatitis B Core Antigen) and Treponema pallidum. Multichem ID-GNeg does not contain analytes for HBsAg, anti-HIV-1 lgG, anti-HCV lgG, anti-HBc lgG, and anti-Treponema pallidum lgG. These controls are provided in liquid form for convenience. Each control is available as either 1 or 4 vials x 4 ml/vial.
Multichem ID-G is manufactured by adding the required analytes to the negative delipidated human serum base matrix, described above. Human disease state plasma that has tested positive for the required analyte using an FDA-cleared/approved assay is used to spike the base matrix to each target specification and within the ranges set for the Roche Immunoassay systems (Tables 1 and 2).
Table 1: Design Input Specifications for Multichem ID-G on the Roche Immunoassays.
| ANALYTES | Product Specification UNITS | Positive When: | TARGET | LOW | HIGH |
|---|---|---|---|---|---|
| Anti-HIV-1 IgG | COI | >1 | 4.0 | 2.5 | 6.0 |
| Anti-HCV IgG | COI | >1 | 10.0 | 3.0 | 12.0 |
| Anti-Treponema pallidum IgG | COI | >1 | 2.0 | 1.5 | 4.0 |
| Anti-HBc IgG | COI | <1 | 0.5 | 0.2 | 0.8 |
| HBsAg | COI | >1 | 2.5 | 1.5 | 5.0 |
Table 2: Specifications for Raw Material Analyte Volume in the final product.
| Analytes | Raw Material I.D. Number | Origin | Raw Material Analyte Volume (mL) |
|---|---|---|---|
| HBsAg | RMR-32108 | Australia | 6.0 mL |
| anti-HIV 1 IgG | RMR-32103 | Australia | 1.5 mL |
| anti-HCV IgG | RMR-32105 | Australia | 0.4 mL |
| anti-Treponema palladium IgG | RMR-32106 | Australia | 28.6 mL |
| anti-HBc IgG | RMR-32107 | Australia | 12.5 mL |
Performance Data
1. Precision/Reproducibility:
A. Precision.
Within-laboratory precision was evaluated using Roche assays Elecsys HIV Duo, Elecsys anti-HCV II, Elecsys Syphilis, Elecsys anti-HBc II and Elecsys HBsAg II. Testing was performed on Roche cobas e 801, using 3 lots of QC material, which were tested in 2 replicates per run, 2 runs per day, for 20 days. The results are summarized in the following table.
Page 8
Table 3. Within-laboratory precision of Multichem ID-G and Multichem ID-GNeg.
| Immunoassay System | QC (POS/NEG) | COI | Repeatability | Within-Laboratory Precision | ||
|---|---|---|---|---|---|---|
| SD (COI) | %CV | SD (COI) | %CV | |||
| anti-HIV | POS | 2.01 | 0.040 | 1.9 | 2.023 | 1.9 |
| NEG | 0.18 | 0.010 | 4.0 | 0.180 | 0.0 | |
| anti-HCV | POS | 11.74 | 0.080 | 0.7 | 0.240 | 2.0 |
| NEG | 0.06 | 0.003 | 3.1 | 0.004 | 6.7 | |
| anti-HBc | POS | 0.53 | 0.006 | 0.0 | 0.014 | 0.0 |
| NEG | 2.29 | 0.030 | 1.3 | 0.030 | 1.3 | |
| HBsAg | POS | 2.96 | 0.075 | 0.0 | 0.108 | 0.0 |
| NEG | 0.37 | 0.023 | 6.2 | 0.025 | 6.9 | |
| anti-T. pallidum | POS | 2.17 | 0.060 | 2.9 | 0.060 | 2.9 |
| NEG | 0.14 | 0.000 | 2.0 | 0.140 | 0.00 |
B. Reproducibility
Reproducibility was evaluated using Roche assays Elecsys HIV Duo, Elecsys anti-HCV II, Elecsys Syphilis, Elecsys anti-HBc II and Elecsys HBsAg II. Testing was performed at 2 sites on analyzers Roche cobas e 801 using 3 QC lots, which were tested in 5 replicates per run, 1 run per day, over 5 days with a total of 150 replicates for each control. The results are summarized in the following table.
Table 4. Reproducibility of Multichem ID-G and Multichem ID-GNeg.
| Immunoassay system | Component | Positive | Negative | ||||
|---|---|---|---|---|---|---|---|
| COI | Standard Deviation (COI) | % CV | COI | Standard Deviation (COI) | % CV | ||
| HIV Ab | Repeatability (Within-Run) | 2.00 | 0.03 | 1.51 | 0.20 | 0.01 | 2.98 |
| Between-Day/Run | 0.01 | 0.57 | 0.00 | 0.00 | |||
| Between-Lot | 0.02 | 1.05 | 0.00 | 1.41 | |||
| Between-Site | 0.20 | 9.23 | 0.00 | 0.96 | |||
| Total Reproducibility | 0.20 | 9.42 | 0.01 | 4.67 | |||
| anti-HCV | Repeatability (Within-Run) | 11.89 | 0.13 | 1.12 | 0.10 | 0.00 | 3.44 |
| Between-Day/Run | 0.07 | 0.55 | 0.00 | 1.90 | |||
| Between-Lot | 0.15 | 1.31 | 0.00 | 0.00 | |||
| Between-Site | 0.09 | 0.76 | 0.00 | 3.93 | |||
| Total Reproducibility | 0.23 | 1.96 | 0.00 | 5.56 | |||
| Anti-HBc | Repeatability (Within-Run) | 0.53 | 0.01 | 1.56 | 2.10 | 0.02 | 1.08 |
| Between-Day/Run | 0.00 | 0.55 | 0.00 | 0.00 | |||
| Between-Lot | 0.01 | 2.33 | 0.00 | 0.14 | |||
| Between-Site | 0.02 | 4.50 | 0.06 | 2.76 | |||
| Total Reproducibility | 0.03 | 5.34 | 0.07 | 2.96 | |||
| Syphilis | Repeatability (Within-Run) | 2.11 | 0.04 | 1.82 | 0.10 | 0.01 | 8.28 |
Page 9
| Between-Day/Run | 0.03 | 1.64 | 0.00 | 3.38 | |||
|---|---|---|---|---|---|---|---|
| Between-Lot | 0.06 | 2.96 | 0.00 | 0.00 | |||
| Between-Site | 0.20 | 10.25 | 0.02 | 13.17 | |||
| Total Reproducibility | 0.22 | 10.95 | 0.02 | 15.92 | |||
| HBsAg | Repeatability (Within-Run) | 3.10 | 0.0928 | 3.0 | 0.42 | 0.0300 | 7.1 |
| Between-Day/Run | 0.0396 | 1.3 | 0.0166 | 3.9 | |||
| Between-Lot | 0.0531 | 1.7 | 0.0000 | 0.0 | |||
| Between-Site | 0.2367 | 7.6 | 0.0644 | 15.3 | |||
| Total Reproducibility | 0.2627 | 8.5 | 0.0730 | 17.3 |
2. Stability
Shelf-life and open vial stability were evaluated using Roche assays Elecsys HIV Duo, Elecsys anti-HCV II, Elecsys Syphilis, Elecsys anti-HBc II and Elecsys HBsAg II. Testing was performed using 3 QC lots stored at 2-8°C and at -80°C. Stability studies supported a shelf-life stability claim of 11 months at the recommended storage conditions (2-8°C) and an open-vial stability claim of 90 days when stored at 2-8°C, for both positive and negative controls.
Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
§ 866.3920 Assayed quality control material for clinical microbiology assays.
(a)
Identification. An assayed quality control material for clinical microbiology assays is a device indicated for use in a test system to estimate test precision or to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device consists of single or multiple microbiological analytes intended for use with either qualitative or quantitative assays.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed device description documentation and information concerning the composition of the quality control material, including, as appropriate:
(i) Analyte concentration;
(ii) Expected values;
(iii) Analyte source;
(iv) Base matrix;
(v) Added components;
(vi) Safety and handling information; and
(vii) Detailed instructions for use.
(2) Premarket notification submissions must include detailed documentation, including line data as well as detailed study protocols and a statistical analysis plan used to establish performance, including:
(i) Description of the process for value assignment and validation.
(ii) Description of the protocol(s) used to establish stability.
(iii) Line data establishing precision/reproducibility.
(iv) Where applicable, assessment of matrix effects and any significant differences between the quality control material and typical patient samples in terms of conditions known to cause analytical error or affect assay performance.
(v) Where applicable, identify or define traceability or relationship to a domestic or international standard reference material and/or method.
(vi) Where applicable, detailed documentation related to studies for surrogate controls.
(3) Premarket notification submissions must include an adequate mitigation (e.g., real-time stability program) to the risk of false results due to potential modifications to the assays specified in the device's 21 CFR 809.10 compliant labeling.
(4) Your 21 CFR 809.10 compliant labeling must include the following:
(i) The intended use of your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following:
(A) Assayed control material analyte(s);
(B) Whether the material is intended for quantitative or qualitative assays;
(C) Stating if the material is a surrogate control; and
(D) The system(s), instrument(s), or test(s) for which the quality control material is intended.
(ii) The intended use in your 21 CFR 809.10(a)(2) and (b)(2) compliant labeling must include the following statement: “This product is not intended to replace manufacturer controls provided with the device.”
(iii) A limiting statement that reads “Quality control materials should be used in accordance with local, state, federal regulations, and accreditation requirements.”