Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)

K242492 · Techno-Path Manufacturing , Ltd. · QCH · Dec 30, 2025 · Microbiology

Device Facts

• Record ID: K242492
• 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)
• Applicant: Techno-Path Manufacturing , Ltd.
• Product Code: QCH · Microbiology
• Decision Date: Dec 30, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3920
• Device Class: Class 2

Indications for 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 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.

Device Story

Multichem ID-G and Multichem ID-GNeg are liquid quality control (QC) materials derived from human plasma; used to monitor precision of Roche cobas immunoassay systems. Multichem ID-G is spiked with specific analytes (HBsAg, anti-HIV-1 IgG, anti-HCV IgG, anti-HBc IgG, anti-Treponema pallidum IgG) to target specifications; Multichem ID-GNeg contains no such analytes. Used in clinical laboratories by technicians/operators; processed alongside patient samples. Healthcare providers compare observed QC results against established target ranges to verify assay performance; ensures reliability of patient test results. Benefits include standardized monitoring of assay precision, reducing risk of erroneous clinical decisions due to instrument or reagent drift.

Clinical Evidence

Bench testing only. Precision and reproducibility evaluated using Roche cobas e 801 analyzers across multiple sites and lots. Precision study (20 days, 2 replicates/run, 2 runs/day) and reproducibility study (150 replicates total) demonstrated acceptable performance metrics (SD and %CV) for all analytes. Stability studies support 11-month shelf-life and 90-day open-vial stability at 2-8°C.

Technological Characteristics

Liquid human plasma-based controls. Analytes: HBsAg, anti-HIV-1 IgG, anti-HCV IgG, anti-HBc IgG, anti-Treponema pallidum IgG. Storage: 2-8°C. Shelf-life: 11 months. Open-vial stability: 30 days. Compatible with Roche cobas e 402 and e 801 systems.

Indications for Use

Indicated for use as qualitative positive and negative quality control serum to monitor precision of laboratory testing procedures for Anti-HBc IgG, Anti-HCV IgG, HBsAg, Anti-Treponema pallidum IgG, and Anti-HIV 1 IgG on Roche cobas heterogeneous immunoassay systems.

Regulatory Classification

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.

Special Controls

An assayed quality control material for clinical microbiology assays must comply with the following special controls: (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; Expected values: (ii) Analyte source: (iii) (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., realtime 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 in your 21 CFR 809.10(a)(2) and 21 CFR 809.10(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; (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 21 CFR 809.10(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."

*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.”

Predicate Devices

• PreciControl Anti-HAV II (K190428)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number

K242492

B Applicant

Techno-Path Manufacturing, Ltd.

C Proprietary and Established Names

Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN)

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QCH | Class II | 21 CFR 866.3920 - Assayed Quality Control Material For Clinical Microbiology Assays | MI - Microbiology |

## II Submission/Device Overview:

### A Purpose for Submission:

Clearance of the Quality Control (QC) material for Roche cobas assays detecting analytes anti-HIV-1 (Human Immunodeficiency Virus Type 1) IgG, anti-HBc (Hepatitis B Core Antigen) IgG, anti-HCV (Hepatitis C Virus) IgG, Hepatitis B Surface Antigen (HBsAg), and anti-Treponema pallidum IgG.

### B Measurand:

- Anti-HIV-1 IgG,
- Anti-HBc IgG,

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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- Anti-HCV IgG,
- HBsAg,
- Anti-Treponema pallidum IgG.

## C Type of Test:

QC materials to monitor the performance of *in-vitro* testing for the qualitative detection of human HBsAg, anti-HIV-1 IgG, anti-HCV IgG, anti-HBc IgG, and anti-Treponema pallidum IgG assays performed with the Roche immunoassays on the Roche cobas systems.

## III Intended Use/Indications for Use:

### A Intended Use(s):

See Indications for Use below.

### B Indication(s) for 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 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.

### C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

### D Special Instrument Requirements:

The performance of Multichem ID-G and Multichem ID-GNeg was evaluated on the Roche cobas systems e 402 (K220134 cleared on 09/16/2022), and e 801 (K162606 cleared on 01/23/2017).

## IV Device/System Characteristics:

### A 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

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Antigen (HBsAg), and IgG antibodies to HIV-1, HCV, HBc and Treponema pallidum.

Multichem ID-GNeg does not contain analytes for HBsAg, anti-HIV-1 IgG, anti-HCV IgG, anti-HBc IgG, and anti-Treponema pallidum IgG. 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 Assays.

| 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 |

B Principle of Operation:

Used as QC in accordance with the assay's Instructions for Use.

V Substantial Equivalence Information:

A Predicate Device Name(s):

Elecsys Anti-HAV II

B Predicate 510(k) Number(s):

K190428

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K190428 | K242492 |
| --- | --- | --- |

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VI Standards/Guidance Documents Referenced:

Special Controls under 21 CFR 866.3920

| 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/ID-GNeg is intended for use as a qualitative positive/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 | | |
| 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°C
Multichem 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 |

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# VII Performance Characteristics (if/when applicable):

# A Analytical Performance:

# 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 that were tested in 2 replicates per run, 2 runs per day, for 20 days. A total of 240 replicates for each control were tested. The results are summarized in table 3.

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 that were tested in 5 replicates per run, 1 run per day, over 5 days. A total of 150 replicates for each control were tested. The results are summarized in table 4.

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 |

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| | 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 |
| | 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. Linearity:

N/A

3. Analytical Specificity/Interference:

N/A

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4. Assay Reportable Range:

N/A

5. Stability:

Stability 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 1 site using 3 QC lots that were tested in 3 replicates at month 0, 11, 24, and 35 for shelf-life at 2-8°C or at days 0, 90, and 91 for open vial stability at 2-8°C.

Stability studies supported a shelf-life claim of 11 months at the intended storage conditions (2-8°C) and open-vial claim of 90 days when stored at 2-8°C. Technopath requested a 30-day open vial claim for Multichem ID-GNeg and Multichem ID-G.

6. Detection Limit:

N/A

7. Assay Cut-Off:

N/A

B Comparison Studies:

1. Method Comparison with Predicate Device:

N/A

2. Matrix Comparison:

N/A

C Clinical Studies:

1. Clinical Sensitivity:

N/A

2. Clinical Specificity:

N/A

3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):

N/A

D Clinical Cut-Off:

N/A

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E Expected Values/Reference Range:

Multichem ID-G and Multichem ID-GNeg are qualitative controls. The expected results are listed in Table 1.

VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.