WINMAX SOFTWARE SYSTEMS

K965103 · Diagnostic Products Corp. · JJF · May 9, 1997 · Clinical Chemistry

Device Facts

• Record ID: K965103
• Device Name: WINMAX SOFTWARE SYSTEMS
• Applicant: Diagnostic Products Corp.
• Product Code: JJF · Clinical Chemistry
• Decision Date: May 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2170
• Device Class: Class 1
• Attributes: Software as a Medical Device

Intended Use

DPC's WinMAX software system is a comprehensive software program for processing DPC's in vitro diagnostic assays, the AlaSTAT and AlaTOP immunodiagnostic allergy test kits, in the microtiter plate format. It is intended for in vitro diagnostic use only.

Device Story

WinMAX software processes data from AlaSTAT and AlaTOP immunodiagnostic allergy test kits; operates in microtiter plate format. Software transforms raw assay measurements into quantitative allergy test results. Used in clinical laboratory settings by laboratory personnel. Output provides quantitative diagnostic information to clinicians for allergy assessment. Benefits include automated data processing and standardized result reporting for allergy diagnostics.

Clinical Evidence

Bench testing only. Comparison study of 262 serum samples tested on both WinMAX and MAXsoftware systems. 163 samples within reportable range showed linear regression: WinMAX = 0.76 * MAXsoftware + 0.91 KU/L; correlation coefficient 0.960.

Technological Characteristics

Software program for processing immunodiagnostic assay data. Operates on microtiter plate format. Quality system: ISO 9002/EN29002/BS 5750.

Indications for Use

Indicated for in vitro diagnostic processing of AlaSTAT and AlaTOP allergy test kits in microtiter plate format.

Regulatory Classification

Identification

A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes.

Reference Devices

• MAXsoftware system

Submission Summary (Full Text)

{0}

K965103

MAY - 9 1997

# 510 (k) Summary
## Safety and Effectiveness

This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.

| Name: | Diagnostic Products Corporation
5700 West 96th Street
Los Angeles, California 90045-5597 |
| --- | --- |
| Address: | |
| Telephone Number: | [phone] |
| Facsimile Number: | [phone] |
| Contact Person: | Edward M. Levine, Ph.D.
Director of Clinical Affairs |
| Date of Preparation: | March 20, 1997 |
| Device Name: | WinMAX software system |
| Trade: | Software program for processing AlaSTAT and AlaTOP
immunodiagnostic allergy test kits. |
| Catalog Number: | WinMAX |
| Classification: | Class I device, (21 CFR 862.2300) |
| Level of Concern: | We believe the level of concern of this device to be minor,
based on definitions established in the "Review Guidance
for Computer Controlled Medical Devices Undergoing
510(k) Review" |
| Hazards associated
with the device: | We believe the hazards associated with malfunction of the
device to be minimal. At the worst, software malfunction
could lead to misdiagnosis of patient allergy. |
| Manufacturer: | EURO/DPC Ltd., a wholly-owned subsidiary of DPC
(Manufacturing under a Quality System-ISO
9002/EN29002/BS 5750) |
| Sole U.S. Importer: | Diagnostic Products Corporation (DPC)
5700 West 96th Street
Los Angeles, CA 90045-5597 |
| Establishment Registration Number: | DPC's Registration Number is 2017183 |
| Description of Device: | Software program |
| Intended Use of the Device: | DPC's WinMAX software system is a comprehensive
software program for processing DPC's in vitro
diagnostic assays, the AlaSTAT and AlaTOP
immunodiagnostic allergy test kits, in the microtiter plate
format. It is intended for in vitro diagnostic use only. |

{1}

Diagnostic Products Corporation
WinMAX Software System
April 10, 1997

## Method Comparison:

To demonstrate the equivalence of the performance of the WinMAX and MAXsoftware systems, a comparison was made of 262 serum samples tested for a variety of allergens using both software systems. Of the 262 samples tested, 163 samples gave quantitative results that were within the reportable ranges of both software systems. Linear regression of these 163 sample results yielded: WinMAX = 0.76 * MAXsoftware + 0.91 KU/L, with a correlation coefficient of 0.960.

## Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that the device is safe and effective.

Edward M. Levine, Ph.D.
Director of Clinical Affairs
4/10/97
Date

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