← Product Code [QSU](/productcode/QSU) · BK261388

# INSTI® HIV-1/HIV-2 Antibody Test (BK261388)

_bioLytical Laboratories, Inc. Canada · QSU · Sep 14, 2026 · Microbiology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/BK261388

## Device Facts

- **Applicant:** bioLytical Laboratories, Inc. Canada
- **Product Code:** [QSU](/productcode/QSU.md)
- **Decision Date:** Sep 14, 2026
- **Decision:** SESE
- **Regulation:** 21 CFR 866.3956
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

The INSTI HIV-1/HIV-2 Antibody Test is a single use, rapid, in vitro qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and/or Type 2 (HIV-1/HIV-2) in human venipuncture whole blood, fingerstick blood, or plasma specimens. The test is intended for use by trained personnel in point of care and laboratory situations to aid in the diagnosis of HIV infections. If multiple rapid HIV tests are available, this test is suitable for use in appropriate multi-test algorithms.

## Device Story

Single-use, rapid, qualitative flow-through immunoassay; detects HIV-1/HIV-2 antibodies in human whole blood or plasma. Device consists of membrane-based test unit in plastic cartridge; uses proprietary liquid reagents (sample diluent, color developer, clarifying solution). Specimen applied to membrane; target antibodies captured by immobilized HIV-1/HIV-2 recombinant proteins; colorimetric signal (blue dot) generated via Protein A-indigo dye conjugate. No instrumentation or electrical power required; visual interpretation of test and control dots. Used in point-of-care and laboratory settings by trained personnel. Provides qualitative results in approximately one minute. Aids in HIV diagnosis; suitable for multi-test algorithms.

## Clinical Evidence

No new clinical data provided; clinical performance evaluation was completed as part of the predicate submission (BP090032). Evidence for current submission consists of non-clinical verification and validation, including equipment/process qualification and comparative analytical studies (limit of detection, repeatability, stability) demonstrating equivalence between manufacturing processes.

## Technological Characteristics

Flow-through immunoassay; nitrocellulose membrane; HIV-1/HIV-2 recombinant protein antigens. Detection via Protein A-indigo dye conjugate (colorimetric). Manual, visual interpretation. No electrical power/instrumentation. Kit includes BMU, sample diluent (Tris-Glycine), color developer (borate-buffered), clarifying solution (Tris-Glycine), lancet, and pipette. Shelf life 15 months at 2–30°C.

## Regulatory Identification

Human immunodeficiency virus (HIV) serological diagnostic and supplemental tests are prescription devices for the qualitative detection of HIV antigen(s) and/or detection of antibodies against HIV in human body fluids or tissues. The tests are intended for use as an aid in the diagnosis of infection with HIV and are for professional use only. The test results are intended to be interpreted in conjunction with other relevant clinical and laboratory findings. These tests are not intended to be used for monitoring patient status, or for screening donors of blood or blood products, or human cells, tissues, and cellular and tissue-based products (HCT/Ps).

## Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) For all HIV serological diagnostic and supplemental tests
(i) The labeling must include:
(A) An intended use that states that the device is not intended for use for screening donors of blood or blood products or HCT/Ps.
(B) A detailed explanation of the principles of operation and procedures used for performing the assay.
(C) A detailed explanation of the interpretation of results and recommended actions to take based on results.
(D) 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:
(
*1* ) The matrices with which the device has been cleared, and that use of this test kit with specimen types other than those specifically cleared for this device may result in inaccurate test results.(
*2* ) The test is not intended to be used to monitor individuals who are undergoing treatment for HIV infection.(
*3* ) A specimen with a reactive result should be investigated further following current guidelines.(
*4* ) All test results should be interpreted in conjunction with the individual's clinical presentation, history, and other laboratory results.(
*5* ) A test result that is nonreactive does not exclude the possibility of exposure to or infection with HIV. Nonreactive results in this assay may be due to analyte levels that are below the limit of detection of this assay.(ii) Device verification and validation must include:
(A) Detailed device description, including the device components, ancillary reagents required but not provided, and an explanation of the methodology. Additional information appropriate to the technology must be included, such as the amino acid sequence of antigen(s) and design of capture antibodies.
(B) For devices with assay calibrators, the design of all primary, secondary, and subsequent quantitation standards used for calibration as well as their traceability to a reference material. In addition, analytical testing must be performed following the release of a new lot of the standard material that was used for device clearance, or when there is a transition to a new calibration standard.
(C) Detailed documentation of analytical performance studies conducted as appropriate to the technology, specimen types tested, and intended use of the device, including, but not limited to, limit of blank, limit of detection, cutoff determination, precision, endogenous and exogenous interferences, cross reactivity, carryover, quality control, matrix equivalency, and sample and reagent stability. Samples selected for use in analytical studies or used to prepare samples for use in analytical studies must be from subjects with clinically relevant circulating genotypes in the United States.
(D) Multisite reproducibility study that includes the testing of three independent production lots.
(E) Analytical sensitivity of the test must be the same as or better than that of other cleared or approved tests. Samples tested must include appropriate numbers and types of samples, including real clinical samples near the lower limit of detection. Analytical specificity of the test must be the same as or better than that of other cleared or approved tests. Samples must include appropriate numbers and types of samples from patients with different underlying illnesses or infections and from patients with potential endogenous interfering substances.
(F) Detailed documentation of performance from a multisite clinical study. Performance must be analyzed relative to an FDA-cleared or approved comparator. This study must be conducted using patient samples, with an appropriate number of HIV positive and HIV negative samples in applicable risk categories. Additional subgroups or types must be validated using appropriate numbers and types of samples. The samples may be a combination of fresh and repository samples, sourced from within and outside the United States, as appropriate. The study designs, including number of samples tested, must be sufficient to meet the following criteria:
(
*1* ) Clinical sensitivity of the test must have a lower bound of the 95 percent confidence interval of greater than or equal to 99 percent.(
*2* ) Clinical specificity of the test must have a lower bound of the 95 percent confidence interval of greater than or equal to 99 percent.(G) Strategies for detection of new strains, types, subtypes, genotypes, and genetic mutations as they emerge.
(H) 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.
(I) 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.
(J) All stability protocols, including acceptance criteria.
(K) Appropriate and acceptable procedure(s) for evaluating customer complaints and other device information that determines when to submit a medical device report.
(L) Premarket notification submissions must include the information contained in paragraph (b)(1)(ii)(A) through (K) of this section.
(iii) Manufacturers must submit a log of all complaints. The log must include the following information regarding each complaint if available: The type of event (
*e.g.,* false negative/false nonreactive or false positive/false reactive), lot, date, population, and whether or not the complaint was reported under part 803 of this chapter (Medical Device Reporting). The log must be submitted annually on the anniversary of clearance for 5 years following clearance of a traditional premarket notification.(2) If the test is intended for Point of Care (PoC) use, the following special controls, in addition to those listed in paragraph (b)(1) of this section apply:
(i) The PoC labeling must include a statement that the test is intended for PoC use.
(ii) The PoC labeling must include the following information near the statement of the intended use:
(A) That the test is for distribution to clinical laboratories that have an adequate quality assurance program, including planned systematic activities that provide adequate confidence that requirements for quality will be met and where there is assurance that operators will receive and use the instructional materials.
(B) That the test is for use only by an agent of a clinical laboratory.
(C) Instructions for individuals to receive the “Subject Information Notice” prior to specimen collection and appropriate information when test results are provided.
(iii) PoC labeling must include instructions to follow current guidelines for informing the individual of the test result and its interpretation.
(iv) The instructions in the labeling must state that reactive results are considered preliminary and should be confirmed following current guidelines.
(v) Device verification and validation for PoC use must include:
(A) Detailed documentation of performance from a multisite clinical study conducted at appropriate PoC sites. Performance must be analyzed relative to an FDA cleared or approved comparator. This study must be conducted using patient samples, with appropriate numbers of HIV positive and HIV negative samples in applicable risk categories. Additional subgroup or type claims must be validated using appropriate numbers and types of samples. The samples may be a combination of fresh and repository samples, sourced from within and outside the United States, as appropriate. If the test is intended solely for PoC use, the test must meet only the performance criteria in paragraphs (b)(2)(v)(A)(
*1* ) and (*2* ) of this section and not the criteria in paragraph (b)(1)(ii)(F) of this section:(
*1* ) Clinical sensitivity of the test must have a lower bound of the 95 percent confidence interval of greater than or equal to 98 percent.(
*2* ) Clinical specificity of the test must have a lower bound of the 95 percent confidence interval of greater than or equal to 98 percent.(B) Premarket notification submissions must include the information contained in paragraph (b)(2)(v)(A) of this section.
(3) If the test is intended for supplemental use in addition to use as an aid in initial diagnosis, the following special controls, in addition to those listed in paragraphs (b)(1) and (2) of this section, as appropriate, apply:
(i) The labeling must include a statement that the test is intended for use as an additional test to confirm the presence of HIV antibodies or antigens in specimens found to be repeatedly reactive by a diagnostic screening test.
(ii) Device validation and verification for supplemental use must include a clinical study, including samples that were initially reactive and repeatedly reactive on a diagnostic test but were negative or indeterminate on a different confirmatory test. Premarket notification submissions must include this information.
(4) If the test is intended solely as a supplemental test, the following special controls, in addition to those listed in paragraphs (b)(1) and (2) of this section, except those in paragraphs (b)(1)(ii)(F) and (b)(2)(v)(A) of this section, as appropriate, apply:
(i) The labeling must include a statement that the test is intended for use as an additional test to confirm the presence of HIV antibodies or antigens in specimens found to be repeatedly reactive by a diagnostic screening test.
(ii) The labeling must clearly state that the test is not for use for initial diagnosis or is not intended as a first-line test.
(iii) Device validation and verification must include a clinical study including samples that were initially reactive and repeatedly reactive on a diagnostic test but were negative or indeterminate on a confirmatory test. Premarket notification submissions must include this information.
(5) If the test is intended to differentiate different HIV types, the following special controls, in addition to those listed in paragraphs (b)(1) through (4) of this section, as appropriate, apply:
(i) The labeling must include the statement that the test is intended for the confirmation of initial results from a diagnostic test and differentiation of different HIV types.
(ii) The results interpretation in the labeling must include instructions for the user on how to interpret the results, including un-typeable and co-infection results.
(iii) Device validation and verification must include evaluation of analytical and clinical sensitivity and specificity for each of the HIV types, strains, and subtypes of HIV intended to be differentiated. Premarket notification submissions must include this information.

## Predicate Devices

- INSTI HIV-1/HIV-2 Antibody Test (BP090032)

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

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[LOGO]

bioLytical®
LABORATORIES

#406 13251 Delf Place

Richmond, BC Canada V6V 2A2

## 510(k) Summary

510(k) #: BK261388

### Contact Details

Applicant Name

Applicant Address

Biolytical Laboratories Inc

Unit 406-13251 Delf Pl Richmond BC V6V2A2

Canada

Applicant Contact Telephone

+1 6042046784

Applicant Contact

Mrs. Ana Subramanian

Applicant Contact Email

asubramanian@biolytical.com

### Device Name

Device Trade Name

INSTI HIV-1/HIV-2 Antibody Test (90-1019)

Common Name

Human immunodeficiency virus (HIV) serological
diagnostic and/or supplemental test

Classification Name

Point Of Care HIV Serology Diagnostic And/Or
Supplemental Test

Registration Number

866.3956

Product Code(s)

QSU

### Legally Marketed Predicate Devices

Predicate #

BP090032

Predicate Trade Name

INSTI HIV-1/HIV-2 Antibody Test

Product Code

QSU

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**bioLytical®**^{}[] LABORATORIES

#406 13251 Delf Place^{}[] Richmond, BC Canada V6V 2A2

## Device Description Summary

The INSTI HIV-1/HIV-2 Antibody Test is a single-use, rapid, qualitative in vitro immunoassay intended for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in human venous whole blood, fingerstick whole blood, or plasma specimens. The test is intended for use by trained healthcare professionals in point-of-care and laboratory settings as an aid in the diagnosis of HIV infection.

### How the device functions

The test utilizes a disposable membrane-based test device together with proprietary liquid reagents to process the specimen and generate a visual result. Following specimen application and sequential addition of the supplied reagents, the sample migrates through the membrane where target antibodies, if present, are captured by immobilized assay reagents. A visible colored reaction develops at designated locations on the membrane, allowing qualitative interpretation of the test and control results without the need for instrumentation.

### Scientific basis

The device is based on flow-through immunoassay technology. HIV-specific antibodies present in the specimen bind to immobilized HIV antigens within the test device. An integrated control reaction confirms proper test function and supports result validity. The assay produces a visually detectable colorimetric signal that is interpreted according to the Instructions for Use.

### Physical and performance characteristics

The test kit consists of a single-use membrane-based test device housed within a plastic cartridge, proprietary reagent solutions, and specimen collection components appropriate for the specimen type. The test does not require external instrumentation or electrical power and provides a qualitative visual result in approximately one minute following completion of the test procedure.

## Intended Use/Indications for Use

The INSTI HIV-1/HIV-2 Antibody Test is a single use, rapid, in vitro qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and/or Type 2 (HIV-1/HIV-2) in human venipuncture whole blood, fingerstick blood, or plasma specimens. The test is intended for use by trained personnel in point of care and laboratory situations to aid in the diagnosis of HIV infections. If multiple rapid HIV tests are available, this test is suitable for use in appropriate multi-test algorithms.

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bioLytical® LABORATORIES

#406 13251 Delf Place
Richmond, BC Canada V6V 2A2

## Indications for Use Comparison

The indications for use are the same as the approved device.

## Technological Comparison

The primary technological characteristics and intended use of the INSTI HIV-1/HIV-2 Antibody Test remain the same as the predicate device, the approved INSTI HIV-1/HIV-2 Antibody Test (BP090032).

The INSTI HIV-1/HIV-2 Antibody Test is a manual, visually interpreted, flow-through immunoassay intended for the qualitative detection of antibodies to HIV-1 and/or HIV-2 in human whole blood (fingerstick or venipuncture) and plasma specimens. The test is based on membrane immunoassay technology and utilizes a disposable test device with integrated assay reagents and a visual colorimetric detection system. The device includes assay and control components that enable detection of HIV-specific antibodies and verification of proper test performance.

The device operates using the same immunological principles as the predicate device, in which HIV-specific antibodies present in the specimen are captured by immobilized assay reagents and generate a visible signal. The procedure control provides confirmation that the test was performed appropriately and that the device functioned as intended.

The modified device maintains the same design, materials, principle of operation, energy requirements, and performance characteristics as the predicate device. No changes have been made to the intended use, assay principle, or fundamental technological characteristics of the device.

Table 1: Similarities and differences between INSTI HIV-1/HIV-2 Antibody Test and the predicate device

|  Device & Predicate Device(s): | Subject Device INSTI HIV-1/HIV-2 Antibody Test | Predicate Device INSTI HIV-1/HIV-2 Antibody Test  |
| --- | --- | --- |
|  Device Trade Name | INSTI HIV-1/HIV-2 Antibody Test | Same  |
|  General Device Characteristic Similarities |  |   |

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[LOGO]

bioLytical®
LABORATORIES

#406 13251 Delf Place

Richmond, BC Canada V6V 2A2

|  Intended Use/Indications For Use | The INSTI HIV-1/HIV-2 Antibody Test is a single use, rapid, in vitro qualitative immunoassay for the detection of antibodies to Human Immunodeficiency Virus Type 1 and/or Type 2 (HIV-1/HIV-2) in human venipuncture whole blood, fingerstick blood, or plasma specimens. The test is intended for use by trained personnel in point of care and laboratory situations to aid in the diagnosis of HIV infections. If multiple rapid HIV tests are available, this test is suitable for use in appropriate multi-test algorithms. | Same  |
| --- | --- | --- |
|  Assay format | Manual, visually read, flow-through immunoassay. | Same  |
|  Detection method | Colorimetric: visible blue dot formation on nitrocellulose membrane via Protein A-indigo dye conjugate. | Same  |
|  Membrane material | Nitrocellulose | Same  |
|  Test spot antigen | HIV-1 and HIV-2 recombinant proteins | Same  |
|  Specimen volume | 50 μL | Same  |
|  Reagent formulations | Sample Diluent (Tris-Glycine buffer with cell lysis reagents), Color Developer (borate-buffered chromatic indicator), Clarifying Solution (Tris-Glycine buffer). | Same  |
|  Result Reading | Visual interpretation of control and test dot formation. | Same  |

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[LOGO]

bioLytical®
LABORATORIES

#406 13251 Delf Place

Richmond, BC Canada V6V 2A2

|  Kit components | Blotted Membrane Unit (BMU), Sample Diluent, Color Developer, Clarifying Solution, lancet, capillary pipette, alcohol swab and Instructions for Use (IFU). | Same  |
| --- | --- | --- |
|  Shelf life | 15 months at 2 to 30°C | Same  |
|  **General Device Characteristic Differences** |  |   |
|  BMU manufacturing process | Addition of (b) (4) BMU assembly line (b) (4) as an alternative process in the manufacturing process. (b) (4) remain as an alternative in the manufacturing process. | BMU is manufactured by (b) (4).  |
|  BMU Pouching process | Addition of (b) (4) as an alternative process. (b) (4) remain as an alternative in the manufacturing process. | (b) (4)  |
|  Finished kit packaging | Addition of automated packaging line. The kit is packaged in tray format with sealed lid. | Manual assembly. The kit is packaged in pouch format.  |
|  BMU Pouch Dimensions | 189 x 114mm | 280 x 111 mm  |

### Non-Clinical and/or Clinical Tests Summary & Conclusions

Non-clinical verification and validation activities were conducted to assess the proposed changes to the (b) (4) BMU Assembly Line, (b) (4) Automated Packaging Line, BMU pouch dimensions, and finished-kit packaging format. Equipment and process qualifications, including installation, operational, cleaning, and performance qualification, demonstrated acceptable equipment functionality, environmental controls, cleaning

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**bioLytical®**^{}[] LABORATORIES

#406 13251 Delf Place^{}[] Richmond, BC Canada V6V 2A2

effectiveness, BMU manufacturing and pouching processes, seal and package integrity, component placement, packaging accuracy, reject detection, and process consistency.

Comparative analytical studies evaluated key performance characteristics, including limit of blank and limit of detection, sample volume, result reading time, repeatability, operating temperature and humidity, analytical sensitivity using seroconversion and low-titer panels, and in-use stability. These studies demonstrated equivalent performance between BMUs manufactured using the previously cleared (b) (4) process and those manufactured using the proposed (b) (4) process.

Real-time stability studies demonstrated equivalent stability between (b) (4)-manufactured and (b) (4)-manufactured BMUs and supported the 15-month shelf-life claim at 2–30°C. Real-time, and post-shipping, studies of finished kits assembled using the Automated Packaging Line met all predefined acceptance criteria at the available timepoints. Overall, all completed verification and validation activities and available stability data met their applicable predefined acceptance criteria, demonstrating that the proposed manufacturing and packaging changes do not adversely affect the safety, effectiveness, performance, or claimed shelf-life of the INSTI HIV-1/HIV-2 Antibody Test.

### **Clinical performance evaluation**

Clinical performance evaluation was completed as part of BP090032. There are no changes to the assay reagents.

### **Conclusion**

The results of the performance qualification and analytical studies demonstrate that the INSTI HIV-1/HIV-2 Antibody Test kits manufactured on automated assembly line and packaged line is as safe, as effective, and performs as well as the predicate device.

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**Source:** [https://fda-staging.innolitics.com/device/BK261388](https://fda-staging.innolitics.com/device/BK261388)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

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