The Anti-HCV Next assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in human adult and pediatric (18 months through 21 years) serum (collected in serum and serum separator tubes) and plasma (collected in sodium heparin, lithium heparin, lithium heparin separator, sodium citrate, disodium EDTA, tripotassium EDTA, dipotassium EDTA, and dipotassium EDTA separator tubes) on the Alinity i system. The Anti-HCV Next assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of hepatitis C virus (HCV) infection in persons with signs and symptoms of hepatitis, persons at risk for HCV infection, and pregnant women. The test does not determine the state of infection or associated disease. Not cleared for use in screening blood, plasma, cell, or tissue donors.
Device Story
Anti-HCV Next is a chemiluminescent microparticle immunoassay (CMIA) for qualitative detection of anti-HCV antibodies in human serum/plasma; performed on the Alinity i system. Procedure: sample, streptavidin-coated paramagnetic microparticles precomplexed with biotinylated HCV constructs, and acridinium-labeled conjugates are incubated to form a sandwich; wash cycle; addition of second acridinium-labeled HCV antigen conjugate; final wash; addition of Pre-Trigger and Trigger solutions. Chemiluminescent reaction measured as relative light units (RLU); RLU directly proportional to anti-HCV concentration. Results compared to active calibration cutoff to determine reactive/nonreactive status. Used in clinical laboratories to aid presumptive diagnosis of HCV infection. Benefits include diagnostic support for pediatric and adult populations.
Clinical Evidence
Clinical study evaluated 256 pediatric specimens (18 months to 21 years). HCV status determined by consensus of comparator and two additional FDA-cleared assays, with HCV RNA testing for indeterminate/reactive results. PPA was 100% (6/6; 95% CI: 60.97-100.00) and NPA was 97.60% (244/250; 95% CI: 94.86-98.90). Supplemental pediatric spiking study (n=59) compared pediatric and adult samples, showing 78% of samples had absolute differences ≤10%.
Technological Characteristics
CMIA technology; uses streptavidin-coated paramagnetic microparticles with biotinylated HCV antigens (E. coli recombinant and synthetic peptide) and acridinium-labeled conjugates. Automated on Alinity i system. Preservatives: sodium azide. Qualitative 1-step/2-step assay. Calibration storage: 30 days.
Indications for Use
Indicated for qualitative detection of anti-HCV antibodies in human serum and plasma. Patient population: adults and pediatric individuals (18 months through 21 years). Intended for use in persons with signs/symptoms of hepatitis, persons at risk for HCV, and pregnant women. Contraindicated for screening blood, plasma, cell, or tissue donors.
Regulatory Classification
Identification
A hepatitis C virus (HCV) antibody test is identified as an in vitro diagnostic device intended for use with human serum, plasma, or other matrices as a prescription device that aids in the diagnosis of HCV infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C infection. The test is not intended for screening blood, plasma, cell, or tissue donors.
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) The labeling required under § 809.10(b) of this chapter must include:
(i) A prominent statement that the test is not intended for the screening of blood, plasma, and cell or tissue donors.
(ii) Limitations, which must be updated to reflect current clinical practice and disease presentation and management. The limitations must include, but are not limited to, statements that indicate:
(A) When appropriate, the performance characteristics of the test have not been established in populations of immunocompromised or immunosuppressed patients or, other special populations where test performance may be affected.
(B) The detection of HCV antibodies indicates a present or past infection with hepatitis C virus, but does not differentiate between acute, chronic, or resolved infection.
(C) The specimen types for which the device has been cleared, and that use of the test with specimen types other than those specifically cleared for this device may result in inaccurate test results.
(D) Test results are to be interpreted by qualified licensed healthcare professionals in conjunction with the individual's clinical presentation, history, and other laboratory results.
(E) A non-reactive test result may occur early during acute infection, prior to development of a host antibody response to infection, or when analyte levels are below the limit of detection of the test.
(iii) A detailed explanation of the principles of operation and procedures for performing the test.
(2) Design verification and validation must include the following:
(i) A detailed device description, including all parts that make up the device, ancillary reagents required but not provided, an explanation of the device methodology, and design of the antigen(s) and capture antibody(ies) sequences, rationale for the selected epitope(s), degree of amino acid sequence conservation of the target, and the design and nature of all primary, secondary, and subsequent standards used for calibration.
(ii) Documentation and characterization (
*e.g.,* supplier, determination of identity, and stability) of all critical reagents (including description of the antigen(s) and capture antibody(ies)), and protocols for maintaining product integrity throughout its labeled shelf life.(iii) Risk analysis and management strategies, such as Failure Modes Effects Analysis and/or Hazard Analysis and Critical Control Points summaries and their impact on test performance.
(iv) Final release criteria to be used for manufactured test lots with appropriate evidence that lots released at the extremes of the specifications will meet the claimed analytical and clinical performance characteristics as well as the stability claims.
(v) Stability studies for reagents must include documentation of an assessment of real-time stability for multiple reagent lots using the indicated specimen types and must use acceptance criteria that ensure that analytical and clinical performance characteristics are met when stability is assigned based on the extremes of the acceptance range.
(vi) All stability protocols, including acceptance criteria.
(vii) Final release test results for each lot used in clinical studies.
(viii) Multisite reproducibility study that includes the testing of three independent production lots.
(ix) Analytical performance studies and results for determining the limit of blank (LoB), limit of detection (LoD), cutoff, precision (reproducibility) including lot-to-lot and/or instrument-to-instrument precision, interference, cross reactivity, carryover, hook effect, seroconversion panel testing, matrix equivalency, specimen stability, reagent stability, and cross-genotype antibody detection sensitivity, when appropriate.
(x) Analytical sensitivity of the test is the same or better than that of other cleared or approved tests.
(xi) Detailed documentation of clinical performance testing from a multisite clinical study. Performance must be analyzed relative to an FDA cleared or approved HCV antibody test, or a comparator that FDA has determined is appropriate. This study must be conducted using appropriate patient samples, with an acceptable number of HCV positive and negative samples in applicable risk categories. Additional relevant patient groups must be validated as appropriate. The samples may be a combination of fresh and repository samples, sourced from geographically diverse areas. The study designs, including number of samples tested, must be sufficient to meet the following criteria:
(A) Clinical sensitivity of the test must have a lower bound of the 95 percent confidence interval of greater than or equal to 95 percent.
(B) Clinical specificity of the test must have a lower bound of the 95 percent confidence interval of greater than or equal to 96 percent.
(3) For any HCV antibody test intended for Point of Care (PoC) use, the following special controls, in addition to those listed in paragraphs (b)(1) and (2) of this section, apply:
(i) Clinical studies must be conducted at PoC sites.
(ii) Additional labeling must include a brief summary of the instructions for use that are appropriate for use in a PoC environment.
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**FDA** U.S. FOOD & DRUG
ADMINISTRATION
September 23, 2026
Abbott Laboratories
Caroline Mendes
Regulatory Affairs Manager
100 Abbott Park Rd., Cp1
Abbott Park, Illinois 60064
Re: K262156
Trade/Device Name: Anti-HCV Next
Regulation Number: 21 CFR 866.3169
Regulation Name: Hepatitis C virus antibody tests
Regulatory Class: Class II
Product Code: MZO
Dated: June 25, 2026
Received: June 26, 2026
Dear Caroline Mendes:
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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K262156 - Caroline Mendes
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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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 Management System Regulation (QMSR) (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 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-
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K262156 - Caroline Mendes
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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, 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
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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: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K262156
Device Name
Anti-HCV Next
# Indications for Use (Describe)
The Anti-HCV Next assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in human adult and pediatric (18 months through 21 years) serum (collected in serum and serum separator tubes) and plasma (collected in sodium heparin, lithium heparin, lithium heparin separator, sodium citrate, disodium EDTA, tripotassium EDTA, dipotassium EDTA, and dipotassium EDTA separator tubes) on the Alinity i system.
The Anti-HCV Next assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of hepatitis C virus (HCV) infection in persons with signs and symptoms of hepatitis, persons at risk for HCV infection, and pregnant women. The test does not determine the state of infection or associated disease.
Not cleared for use in screening blood, plasma, cell, or tissue donors.
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 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
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# 510(k) Summary
This summary of the 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
## I. 510(k) Number
K262156
## II. Applicant Name
Abbott Laboratories
Department C2D2
100 Abbott Park Road
Abbott Park, IL 60064
Primary contact person for all communications:
Caroline Mendes, Regulatory Affairs Manager
Abbott Diagnostic Division
Telephone Number: (224) 668-3173
Fax Number: (224) 667-4836
Secondary contact person for all communications:
Mark Paradowski, Sr. Director Regulatory Affairs
Abbott Diagnostics Division
Telephone Number: (224) 668-1188
Fax Number: (224) 667-4836
Date summary prepared: September 22, 2026
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### III. Device Name
Anti-HCV Next (also referred to as AntiHCVNx)
Trade Name: Anti-HCV Next
Device Classification: Class II, Special Controls
Classification Name: Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Governing Regulation: 21 CFR 866.3169
Code: MZO
### IV. Predicate Device
DiaSorin LIAISON XL Murex HCV Ab (P190011)
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## V. Description of Device
### Reagents
The kit configuration of the Anti-HCV Next Reagent Kit is described below.
| List Number (LN) | 06T7921 | 06T7931 |
| --- | --- | --- |
| Tests per cartridge | 100 | 500 |
| Number of cartridge sets per kit | 2 | 2 |
| Tests per kit | 200 | 1000 |
| Microparticles | 6.6 mL | 27.0 mL |
| Conjugate 1 | 4.2 mL | 13.8 mL |
| Assay Diluent | 5.9 mL | 14.0 mL |
| Conjugate 2 | 6.1 mL | 26.5 mL |
- Microparticles: Streptavidin-coated microparticles precomplexed with biotinylated HCV antigen (Escherichia coli [E coli], recombinant) and biotinylated HCV core synthetic peptide in pyrophosphate-buffered saline with surfactants. Minimum concentration: 0.05% solids. Preservative: sodium azide.
- Conjugate 1: Acridinium-labeled HCV antigen (E coli, recombinant) and acridinium-labeled HCV core synthetic peptide conjugate in pyrophosphate-buffered saline. Minimum concentration: 10 ng/mL. Preservative: sodium azide.
- Assay Diluent: Pyrophosphate buffer with protein additives (bovine) and detergent. Preservatives: sodium azide and antimicrobial agents.
- Conjugate 2: Acridinium-labeled HCV antigen (E coli, recombinant) conjugate in pyrophosphate-buffered saline. Minimum concentration: 0.01 ng/mL. Preservative: sodium azide.
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# Biological Principles of the Procedure
This assay is an automated, combined one-step/two-step immunoassay for the qualitative detection of anti-HCV in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology.
Sample, streptavidin-coated paramagnetic microparticles precomplexed with biotinylated HCV constructs, acridinium-labeled recombinant and peptide conjugates, and assay diluent are combined and incubated. The anti-HCV present in the sample binds to the HCV coated microparticles and to the acridinium-labeled conjugates, forming a sandwich. The mixture is washed. In a second step, additional acridinium-labeled HCV antigen conjugate is added to create a reaction mixture and incubated. Following a wash cycle, Pre-Trigger and Trigger Solutions are added.
The resulting chemiluminescent reaction is measured as a relative light unit (RLU). There is a direct relationship between the amount of anti-HCV in the sample and the RLU detected by the system optics.
The presence or absence of anti-HCV in the sample is determined by comparing the chemiluminescent RLU in the reaction to the cutoff RLU determined from an active calibration.
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## VI. Intended Use of the Device
The Anti-HCV Next assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in human adult and pediatric (18 months through 21 years) serum (collected in serum and serum separator tubes) and plasma (collected in sodium heparin, lithium heparin, lithium heparin separator, sodium citrate, disodium EDTA, tripotassium EDTA, dipotassium EDTA, and dipotassium EDTA separator tubes) on the Alinity i system.
The Anti-HCV Next assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of hepatitis C virus (HCV) infection in persons with signs and symptoms of hepatitis, persons at risk for HCV infection, and pregnant women. The test does not determine the state of infection or associated disease.
**WARNING:** Not cleared for use in screening blood, plasma, cell, or tissue donors.
## VII. Comparison of Technological Characteristics
The Anti-HCV Next assay (subject device) utilizes a CMIA methodology for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) and is intended for use on the Alinity i system.
The similarities and differences between the subject device and the predicate device are presented in the following tables.
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# Assay Similarities
| Characteristics | Subject Device Anti-HCV Next (To Be Determined) | Predicate Device DiaSorin LIAISON XL Murex HCV Ab P190011 |
| --- | --- | --- |
| Methodology | Chemiluminescent microparticle immunoassay (CMIA) | Chemiluminescent immunoassay (CLIA) |
| Intended Use and Indications for Use | The Anti-HCV Next assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in human adult and pediatric (18 months through 21 years) serum (collected in serum and serum separator tubes) and plasma (collected in sodium heparin, lithium heparin, lithium heparin separator, sodium citrate, disodium EDTA, tripotassium EDTA, dipotassium EDTA, and dipotassium EDTA separator tubes) on the Alinity i system. The Anti-HCV Next assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of hepatitis C virus (HCV) infection in persons with signs and symptoms of hepatitis, persons at risk for HCV infection, and pregnant women. The test does not determine the state of infection or associated disease. **WARNING:** Not cleared for use in screening blood, plasma, cell, or tissue donors. | The LIAISON XL MUREX HCV Ab assay is an *in vitro* chemiluminescent immunoassay (CLIA) for the qualitative determination of specific antibodies to hepatitis C virus (anti-HCV) in human adult and pediatric (2-21 years) serum and plasma (lithium and sodium heparin, sodium citrate and di-potassium EDTA) samples including separator tubes, on the LIAISON XL Analyzer. It is intended to be used as an aid in the diagnosis of HCV infection. The assay may also be used as an aid in the diagnosis of HCV infection in pediatric subjects and in pregnant women. The test does not determine the state of infection or associated disease. The assay is not intended for use in screening blood, plasma, or tissue donors. |
| Assay Type | Qualitative, 1-step/2-step | Qualitative 2-step |
| Type of Specimen | Serum and Plasma | Serum and Plasma |
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# Assay Similarities (Continued)
| Characteristics | Subject Device Anti-HCV Next (To Be Determined) | Predicate Device DiaSorin Liaison XL Murex HCV Ab P190011 |
| --- | --- | --- |
| Interpretation of Results | ≥ 1.00 S/CO Reactive 0.00 to < 0.90 S/CO Nonreactive 0.90 to < 1.00 S/CO Grayzone Grayzone Instruction: Retest in duplicate • If 2 results are ≥ 1.00 S/CO: Reactive. • If 2 or 3 results (including initial result) are < 1.00 S/CO: Nonreactive S/CO = signal of sample / signal of cutoff. | ≥ 1.00 S/CO Reactive < 0.80 S/CO Nonreactive ≥ 0.80 < 1.00 are equivocal Equivocal Instruction: Retest in duplicate. • Reactive if 2 out of 3 retests are ≥ 1.0 S/CO. • Nonreactive if 2 out of 3 retests are < 1.0 S/CO. |
| Cut Off | 1.00 S/CO | 1.00 S/CO |
| Capture Antigens | Streptavidin-coated microparticles precomplexed with biotinylated NS3h antigen and Core Peptide | Magnetic particle coated with HCV core and NS4 recombinant antigens, streptavidin-coated magnetic microparticles and aqueous Biotinylated HCV Nonstructural protein 3 (NS3) recombinant antigen. |
| Calibrator(s) | 1 Calibrator | 1 Calibrator |
| Control(s) | 2 Controls (1 Negative, 1 Positive) Negative Control (negative recalcified human plasma) Positive Control (recalcified, heat-inactivated, human plasma reactive for anti-HCV) | Controls (1 Negative, 1 Positive) Negative Control (human serum/plasma non-reactive for HCV antigens and antibodies) Positive Control (inactivated human serum/plasma reactive for HCV antibodies) |
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# Assay Differences
| Characteristics | Subject Device Anti-HCV Next (To Be Determined) | Predicate Device DiaSorin Liaison XL Murex HCV Ab P190011 |
| --- | --- | --- |
| Components | Microparticles – Streptavidin-coated microparticles precomplexed with biotinylated HCV antigen (E coli, recombinant) and biotinylated HCV core synthetic peptide in pyrophosphate-buffered saline with surfactants. Minimum concentration: 0.05% solids. Preservative: sodium azide. Conjugate 1 – Acridinium-labeled HCV antigen (E coli, recombinant) and acridinium-labeled HCV core synthetic peptide conjugate in pyrophosphate-buffered saline. Minimum concentration: 10 ng/mL. Preservative: sodium azide. Conjugate 2 – Acridinium-labeled HCV antigen (E coli, recombinant) conjugate in pyrophosphate-buffered saline. Minimum concentration: 0.01 ng/mL. Preservative: sodium azide. Assay Diluent – Pyrophosphate buffer with protein additives (bovine) and detergent. Preservatives: sodium azide and antimicrobial agents. | Magnetic particles [SORB] - Magnetic particles coated with HCV core and NS4 recombinant antigens (produced in baculovirus and E. coli respectively), streptavidin-coated magnetic particles, BSA, PBS buffer, EDTA, preservatives. HCV NS3 Antigen [Ag] -Biotinylated HCV NS3 recombinant antigen (produced in E.coli), MES buffer, preservatives. Conjugate [CONJ] - Mouse monoclonal IgG to human IgG conjugated to an isoluminol derivative, fetal calf serum, phosphate buffer, 0.2% ProClin® 300, preservatives, an inert red dye. Specimen diluent [DIL|SPE] - BSA, casein, non-specific recombinant protein (produced in E.coli), phosphate buffer, EDTA, preservatives, an inert blue dye. |
| Calibration Storage | Maximum of 30 days | Maximum of 8 weeks |
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### VIII. Summary of Nonclinical Performance
The following nonclinical performance characteristics of the Anti-HCV Next for Alinity i assay are provided in K252424.
- Within-Laboratory Precision (20-Day)
- Seroconversion Sensitivity
- Analytical Specificity/Interference (Potentially Interfering Endogenous Substances, Potentially Interfering Drugs, Other Specimen Conditions or Disease States)
- Genotype Detection
- High Dose Hook
- Tube Type Equivalence
### IX. Summary of Clinical Performance
#### A. Expected Values
Representative performance data are provided in this section. Results obtained in individual laboratories may vary.
It is recommended that each laboratory determine its own reference range based upon its particular locale and population characteristics.
Of the 3856 specimens tested in the Anti-HCV Next clinical study, 1840 (47.7%) were from adults (> 21 years of age) with signs and symptoms of hepatitis, 1510 (39.2%) were from adults at risk for HCV infection, 250 (6.5%) were from pregnant females, and 256 (6.6%) were from pediatric individuals (≤ 21 years of age).
Testing of these specimens was performed at 4 clinical sites located in Charleston, SC; Temple, TX; Pompano Beach, FL; and Baltimore, MD.
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A demographic summary is provided in the following table.
| | Population | | | | |
| --- | --- | --- | --- | --- | --- |
| | Overall (n=3856) | Adults | | Pregnant Females (n=250) | Pediatric (n=256) |
| | | Signs and Symptoms of Hepatitis (n=1840) | At Risk for HCV Infection (n=1510) | | |
| **Race / Ethnic Group n (%)** | | | | | |
| Black or African American | 1733 (44.9) | 773 (42.0) | 864 (57.2) | 29 (11.6) | 67 (26.2) |
| White | 1684 (43.7) | 1003 (54.5) | 423 (28.0) | 87 (34.8) | 171 (66.8) |
| More Than One Reported | 38 (1.0) | 5 (0.3) | 29 (1.9) | 1 (0.4) | 3 (1.2) |
| Asian | 32 (0.8) | 21 (1.1) | 8 (0.5) | 3 (1.2) | 0 (0.0) |
| American Indian or Alaska Native | 19 (0.5) | 7 (0.4) | 10 (0.7) | 2 (0.8) | 0 (0.0) |
| Native Hawaiian or Other Pacific Islander | 11 (0.3) | 6 (0.3) | 2 (0.1) | 3 (1.2) | 0 (0.0) |
| Other | 3 (0.1) | 1 (0.1) | 1 (0.1) | 1 (0.4) | 0 (0.0) |
| Unknown / Not Reported | 336 (8.7) | 24 (1.3) | 173 (11.5) | 124 (49.6) | 15 (5.9) |
| **Sex n (%)** | | | | | |
| Male | 1946 (50.5) | 1009 (54.8) | 822 (54.4) | N/A | 115 (44.9) |
| Female | 1909 (49.5) | 830 (45.1) | 688 (45.6) | 250 (100.0) | 141 (55.1) |
| Unknown | 1 (0.0) | 1 (0.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| **Age Mean (Range)** | | | | | |
| Years | 43 (1 - 94) | 48 (22 - 94) | 44 (22 - 89) | 26 (16 - 42) | 16 (21 Months – 21 Years) |
N/A = Not Applicable
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# Pediatric
The distribution of Anti-HCV Next reactive and nonreactive results among the pediatric population by age is summarized in the following table.
| Age Range | Number of Reactives (%) | Number of Nonreactives (%) | Total |
| --- | --- | --- | --- |
| 18 Months to 12 Years | 5 (16.13) | 26 (83.87) | 31 |
| 13 to 21 Years | 7 (3.11) | 218 (96.89) | 225 |
| Total | 12 (4.69) | 244 (95.31) | 256 |
The distribution of Anti-HCV Next reactive and nonreactive results among adult individuals with signs and symptoms of hepatitis or at risk for HCV infection, as well as pregnant females, is provided in K252424.
Anti-HCV Next for Alinity i – Pediatric Population 510(k)
510(k) Summary
Page 11 of 14
{15}
## B. System Reproducibility
Reproducibility of the Anti-HCV Next for Alinity i assay is provided in K252424.
## C. Percent Agreement
A clinical study was performed based on guidance from CLSI EP12, 3rd ed.
A total of 256 specimens from pediatric individuals were evaluated using the Anti-HCV Next assay and a commercially available anti-HCV assay (comparator). Specimens reactive by the comparator assay were tested using 2 additional FDA-cleared anti-HCV devices. The consensus of the test results from the comparator assay and the 2 additional FDA-cleared anti-HCV devices was used to determine the intermediate HCV status. Specimens with an Intermediate HCV status of “Reactive” or “Indeterminate” were further tested with an FDA-cleared HCV RNA assay to determine final HCV status. Percent agreement for the Anti-HCV Next assay was determined using the HCV status.
The algorithm used to determine the HCV status is shown in the following table.
| Anti-HCV Comparator | Anti-HCV Assay 2 | Anti-HCV Assay 3 | Intermediate HCV Status | HCV RNA Result | HCV Status |
| --- | --- | --- | --- | --- | --- |
| Nonreactive | N/A | N/A | Nonreactive | N/A | Not Infected |
| Reactive | Reactive | Reactive | Reactive | Reactive | Infected (Active) |
| | | | | Nonreactive | Infected (Resolved) |
| | Reactive | Nonreactive/Equivocal^{a} | Reactive | Reactive | Infected (Active) |
| | | | | Nonreactive | Infected (Resolved) |
| | Nonreactive/Equivocal^{a} | Reactive | Reactive | Reactive | Infected (Active) |
| | | | | Nonreactive | Infected (Resolved) |
| | Equivocal^{a} | Equivocal^{a}/Nonreactive | Indeterminate | Reactive | Infected (Active) |
| | | | | Nonreactive | Indeterminate |
| | Nonreactive | Equivocal^{a} | Indeterminate | Reactive | Infected (Active) |
| | | | | Nonreactive | Indeterminate |
| | Nonreactive | Nonreactive | Nonreactive | N/A | Not Infected |
N/A = Not Applicable
$^{a}$ Equivocal represents samples whose final interpretations fall within the result area between nonreactive and reactive per each manufacturer’s labeling.
Anti-HCV Next for Alinity i – Pediatric Population 510(k)
510(k) Summary
Page 12 of 14
{16}
The positive percent agreement (PPA) and negative percent agreement (NPA) are shown in the following table.
| Specimen Category | Number Tested | HCV Status | | | | | | PPA (%) (95% CI) | NPA (%) (95% CI) |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | HCV Infected | | Indeterminate | | HCV Not Infected | | | |
| | | R | NR | R | NR | R | NR | | |
| Pediatric | 256 | 6 | 0 | 0 | 0 | 6 | 244 | 100.00(6/6)(60.97, 100.00) | 97.60(244/250)(94.86, 98.90) |
R = Reactive; NR = Nonreactive; CI = Confidence Interval
Adult individuals with signs and symptoms of hepatitis or at risk for HCV infection, as well as pregnant females, were evaluated in K252424. The PPA and NPA are reported in K252424.
### D. Pediatric Spiking Study
Due to the low anti-HCV positive prevalence within the pediatric population, a supplemental study was conducted to evaluate the results observed when serum samples from pediatric individuals were tested with the Anti-HCV Next assay. A total of 59 pediatric (aged 17 months to 21 years) and 59 adult negative serum specimens were paired and spiked with anti-HCV positive specimens to yield samples at approximately 2 to 3 times the assay cutoff. The distribution of the absolute % differences between the pediatric and paired adult samples is presented in the following table.
| Age Range | n | Distribution of Absolute Percent Differences | | |
| --- | --- | --- | --- | --- |
| | | ≤ 10% | > 10% to ≤ 20% | > 20% to < 30% |
| 17 Months to 12 Years | 23 | 69.6%(16/23) | 21.7%(5/23) | 8.7%(2/23) |
| 13 to 21 Years | 36 | 83.3%(30/36) | 11.1%(4/36) | 5.6%(2/36) |
| Total | 59 | 78.0%(46/59) | 15.3%(9/59) | 6.8%(4/59) |
Anti-HCV Next for Alinity i – Pediatric Population 510(k)
510(k) Summary
Page 13 of 14
{17}
# X. Conclusion Drawn from Nonclinical and Clinical Laboratory Studies
The results presented in this 510(k) premarket notification demonstrate that the subject device (Anti-HCV Next) performance is substantially equivalent to the predicate assay (DiaSorin LIAISON XL Murex HCV Ab P190011).
Anti-HCV Next for Alinity i – Pediatric Population 510(k)
510(k) Summary
Page 14 of 14
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Learn the FDA Browser
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only Software as a Medical Device, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (Software as a Medical Device), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
