← Product Code [JOZ](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ) · K163274

# AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument (K163274)

_Aggredyne, Inc. · JOZ · Apr 5, 2017 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K163274

## Device Facts

- **Applicant:** Aggredyne, Inc.
- **Product Code:** [JOZ](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ.md)
- **Decision Date:** Apr 5, 2017
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 864.5700
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Indications for Use

The AggreGuide device is intended for patients for whom detecting platelet dysfunction in response to arachidonic acid may be desirable, such as those who are on or are candidates for antiplatelet therapy.

## Device Story

AggreGuide A-100 is an instrument for analyzing platelet-aggregation-induced light scattering. Device uses laser diode to generate light; light interacts with platelet samples; scattering signals are measured to assess aggregation. Modifications include replacement of laser diode with QSI QL78165A-L; updated Quality Control (QC2) cartridge using fixed diffuser instead of rotating groove; software revision (v5.10) to support QC2; shelf-life extension for test cartridges to 19 months. QC2 testing uses steady light for optics verification and oscillating light for amplifier verification. Device operates in clinical settings; provides pass/fail results for QC and platelet aggregation data for clinical decision-making.

## Clinical Evidence

No clinical data. Bench testing only. Verification and validation activities included laser diode performance testing, QC2 implementation verification, software validation, and stability testing (isochronous paradigm) to support 18-month shelf life.

## Technological Characteristics

Laser light scattering system. Components: instrument and disposable cartridges. Laser diode: QSI QL7816SA-L. Agonist: 1 mM Arachidonic Acid. Sample: 164 μL 3.2% citrated whole blood. Connectivity: Factory calibrated. Software: Version 5.10. Risk management: ISO 14971:2007.

## Regulatory Identification

An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.

## Predicate Devices

- AggreGuide A-100 Instrument and AggreGuide A-100 AA assay ([K122162](/device/K122162.md))

## Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification OIR Decision Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K163274

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the SUBMITTER'S previously cleared device: AggreGuide A-100 Instrument and AggreGuide A-100 AA assay (K122162).
2. Submitter's statement indicated that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use and package labeling.
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail, demonstrated that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

The changes were for hardware modification, software revision, stability extension and User's Manual revision. The detailed information of the changes is stated below.

a. New Laser Diode material

The laser diode manufactured by Sanyo, a key component of the AggreGuide A-100, that generates the laser light used to analyze the platelet-aggregation-induced light scattering was replaced with the laser diode manufactured by QSI and the electrical and optical characteristics of the diodes is summarized in table below. Both Laser diodes demonstrate similar specifications and the use of the substitute laser diode have been validated with the AggreGuide A-100 instruments. The validation results meet the production acceptance criteria. The validation protocol and results summary are included in document of "VAL-0110-A" and it can be found in DocMan.

|  Characteristic of Laser | Sanyo DL-4140-001S | QSI QL78165A-L  |
| --- | --- | --- |
|  Wavelength, (nm), nominal | 785 | 785  |
|  Optical Power (mW), required, maximum | 5-20 | 5-20  |
|   |  25 | 30  |
|  Temperature Range(℃) | -10 – 60 ℃ | -10 – 60 ℃  |
|  Operating Current (mA) < 200 | 65 | 45  |
|  Light beam format | Elliptical | Elliptical  |

b. Quality Control Cartridge

The QC device (QC2) has been modified to use a fixed diffuser instead of a rotating groove. There are no changes to the principle of how the QC device is used, and there are no changes to the procedure that the user follows. The changes that have been made to the quality control device pertain to the material used to produce the scattering signal in the QC2 device and to the form of the QC2 device, relative to the previous QC cartridge. The QC2 device reduces the possibility of false negative QC check results and variability of QC results. The stability and repeatability verification study was performed on four production prototype QC2 devices and the results demonstrated that the criteria for stability of time is

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passed and the standard deviation for each device sample was less than  $10\%$  of the mean. The criterion for repeatability between devices is also passed and all means are within  $0.4 \pm 0.05\mathrm{V}$ . The verification protocol and results summary are included in document of "VAL-0102-A" and can be found in DocMan.

# c. Software Changes

The software is revised to accommodate the quality control cartridge modifications (QC2). The functional detail of the software changes are documented in table below:

|  Software Function | Version 5.00 | Version 5.10  |
| --- | --- | --- |
|  Quality control (QC) cartridge | Original (QC) | New (QC2)  |
|  QC software invoked: | Single software entry-point to quality control routine, single point return, simple pass/fail result. | Single software entry-point to quality control routine, single point return, simple pass/fail result. No change.  |
|  Laser power for quality control testing | Power decreased to slightly higher than the lasing threshold. Different than actual blood platelet test. | Power kept at nominally full power settings of the laser, as during actual blood platelet test.  |
|  Laser status during quality control testing | Constant, uses rotation of rotor to cause transient signals. Failure in optics or amplifier observed. | Steady state for test of optics. Oscillating for test of amplifier. Failure of optics alone, or optics plus amplifier observed.  |
|  Quality control cartridge matched to instrument | Each individual QC cartridge is married to an individual instrument. | QC2 cartridges use standard-performing optical materials to allow interchangeability of QC2 cartridges  |

The new QC2 quality control software allows for testing of the QC2 cartridge at the same power level as an assay using whole blood, introduction of a steady light level to test instrument optics and an oscillating light level to test the amplifier.

# d. The Test Cartridge shelf-life Extension

The test cartridge shelf life has been extended from 12 months to 19 months, using the same isochronous stability testing scheme as described in the original  $510(\mathrm{k})$  clearance. The shelf-life stability study was performed using three lots of the cartridges according to the CLSI guidelines EP25-A and EN134460:20002. Results of the shelf-life stability testing were assessed for each lot in terms of measurand drift as stated in CLSI EP25-A, Evaluation of Stability of In Vitro Diagnostics Reagents, Approved Guideline. The study results demonstrate the assay cartridge is stable for at least 20 months of shelf life and support the shelf-life stability extension claim of 18 months. The verification protocol and results summary are included in document of "VAL-0091-B and can be found in DocMan.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including labeling, intended use/indication for use, methodology, insert sheet, physical characteristics are located in 510(k) Summary.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

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The risk analysis methods are determined by the identification of known and hypothesized hazards and estimation of the associated risk based on the operation of the device for its intended use. The design verification and validation tests that were performed as a result of this risk analysis assessment are listed in ANL-0015B (Appendix A). In conclusion, the design changes proposed do not affect system performance and the impact of the modification does not raise additional safety concerns.

b) Based on the risk analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

Descriptions of verification and validation activities were provided for the AggreGuide A-100 hardware and software. The test protocols information and risk management report were also provided.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in the New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K163274](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K163274)

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