← Product Code [JPA](/productcode/JPA) · K061014

# ACTALYKE QC KIT, MODELS  AQC-HP AND AQC-LP (K061014)

_Helena Laboratories · JPA · May 10, 2006 · Hematology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K061014

## Device Facts

- **Applicant:** Helena Laboratories
- **Product Code:** [JPA](/productcode/JPA.md)
- **Decision Date:** May 10, 2006
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 864.5425
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Indications for Use

The Actalyke QC Kits are used to perform quality control assays when using the Actalyke Activated Clotting Time test systems. Blood coagulation instruments and test systems are used in hospitals and/or catherization labs. The AQC-LP is used as a control when the Actalyke system monitors moderately heparinized patients undergoing ECMO procedures or renal dialysis. The AQC-HP is used for QC testing when the Actalyke system is monitoring normal and highly heparinized patients undergoing cardiovascular procedures.

## Device Story

Device modification involves removal of hemoglobin component from product formulation; results in product name change. Fundamental scientific technology remains unchanged. Design control activities, including risk analysis and verification/validation, performed to confirm safety and performance post-modification.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Modified formulation (hemoglobin removed).

## Regulatory Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

## Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER K061014

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 (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement 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, package labeling, and, if available, advertisements or promotional materials.
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

The modification is the removal of hemoglobin in the product formulation, which also results in a change in the product name.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and stability. The difference is in the formulation of the product, with the removal of the hemoglobin component, and a change in the product name.
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
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
c) A declaration of conformity with design controls. The declaration of conformity should include:
i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

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.

(Reviewer's Signature)
(Date)

Comments

Revised: 3/27/98

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**Source:** [https://fda-staging.innolitics.com/device/K061014](https://fda-staging.innolitics.com/device/K061014)

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