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510(k) Data Aggregation
K Number
K953598Device Name
SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS
Manufacturer
SERONO DIAGNOSTICS, INC.
Date Cleared
1996-03-11
(223 days)
Product Code
GKZ
Regulation Number
864.5220Why did this record match?
Applicant Name (Manufacturer) :
SERONO DIAGNOSTICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Each of the four models within the Series 9100+ PLUS (i.e., Model 9120, Model 9118, Model 9110, and Model 9100 Rx) is intended for use as a fully automated hematology cell counter for the in vitro diagnostic testing of whole blood specimens. The Series 9100+ PLUS also is intended to flag or identify specimens containing abnormal blood cells.
Device Description
The Series 9100+ PLUS is comprised of four models of hematology analyzers: Models 9120, 9118, 9110, and 9100 Rx. The most advanced hematology analyzer of the four models (i.e., the model with the greatest number of testing parameters) is the Model 9120, testing a total of 20 parameters. The other models in the Series 9100+ PLUS (i.e., Models 9118, 9110, and 9100 Rx) have exactly the same technological design and electronics as the Model 9120, except that each of these three models lacks one or more of the testing parameters and/or features offered by the Model 9120. This downgrading is achieved in models other than the Model 9120 simply by suppressing or eliminating the software functions that would otherwise allow each of those analyzers to test all of the possible parameters.
Three of the four models in the Series 9100+ PLUS (i.e., Models 9120, 9118, and 9100 Rx) contain a built-in 5-, 3-. or 1-Part Differential software package (respectively) that has the ability to perform interpretive 5-part and quantitative 3or 1-part white cell histogram differentials.
The interpretive report for the Model 9120 and the quantitative reports for the Model 9118 and the Model 9100Rx removes subjectivity and provides possible suggestions of interpretation of the white cell, and platelet histograms based on a computer comparison of the histogram pattern with a multiplicity of pre-set limits. The interpretive report for the Model 9120 does not provide positive identification of cell types, but it alerts the user to the possible presence of abnormally high or low concentrations of normal cell types, abnormal cell types, and abnormally small or large sizes of normal cell types. Both the interpretive and the quantitative reports also provide one or more messages that categorize suspected abnormalities.
The rate of determination for each model in the Series 9100+ PLUS is approximately one sample per 1.33 minutes. This rate includes the time from introduction of the whole blood sample to sample analysis, along with the display and printing of the test results. The system is totally automated with an internal dilution system.
Each model in the Series 9100+ PLUS has a cap piercer module that permits sampling of the blood specimens without removing the stopper from the blood vacuum collection tube. An "AutoSampler" module (denoted by the term "Ax") is optional and allows for the automatic mixing and sampling of multiple EDTAanticoagulated blood specimens from a batch of closed 5 mL vacuum tubes. The AutoSampler also has a Bar Code Scanner option which enables the automatic identification entry of tubes labeled with a standard bar code. Additionally, a manual Bar Code Scanner is available which functions independently of the the AutoSampler, and the user may add the Bar Code Scanner option to each model of the Series 9100+ PLUS without adding the AutoSampler module.
A blood sample can be introduced to the hematology analyzer by one of five methods: (1) the whole blood mode (through the sample probe); (2) the prediluted (fingerstick) sample mode; (3) the platelet-rich plasma mode; (4) the cap piercer mode; or (5) the "Ax" option. Each model of hematology analyzer within the Series 9100+ PLUS uses the same methods to measure the given parameters. The Series 9100+ PLUS makes use of several reagents and supplies.
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