IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE

K093861 · Iris International, Inc. · LKM · Feb 5, 2010 · Hematology

Device Facts

• Record ID: K093861
• Device Name: IQ 20 SERIES ANALYZER, IQ 200 SERIES SYSTEM, NAD IQ LAMINA CRADLE
• Applicant: Iris International, Inc.
• Product Code: LKM · Hematology
• Decision Date: Feb 5, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5200
• Device Class: Class 2

Indications for Use

The iQ® 200 Analyzer/System is intended for the automated analysis of urine specimens.

Device Story

iQ® 200 Analyzer/System; automated urine microscopy analyzer. Modification: addition of iQ® Lamina Cradle accessory. Function: tracks reagent consumption; provides visual warning flags and audio alerts for reagent levels. Used in clinical laboratories; operated by laboratory personnel. Output: automated microscopy results; reagent status alerts. Benefit: ensures reagent availability; prevents analysis interruption.

Clinical Evidence

No clinical tests were performed with the addition of the Lamina Cradle. Bench testing only.

Technological Characteristics

Automated urine microscopy analyzer; accessory (Lamina Cradle) added for reagent tracking. Sensing principle: automated detection of reagent consumption. Connectivity: integrated system. Software: firmware for reagent monitoring and alert generation.

Indications for Use

Indicated for routine urinalysis in patients undergoing clinical evaluation, physical exams, or monitoring for metabolic, systemic, renal, or urinary tract disease/dysfunction, infection, carcinoma, or therapy effectiveness. Used for analysis of urine chemistry, specific gravity, and formed sediment elements.

Regulatory Classification

Identification

An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.

Predicate Devices

• iQ® 200 Analyzer/System (K022774)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K093861

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 iQ® 200 Analyzer/System, K022774, previously cleared device.
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 (labeling changes are permitted as long as they do not affect the intended use).
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.

This change was for the addition of the iQ® Lamina Cradle, an accessory to be used with IQ® Series of Urine Microscopy Analyzers. The Lamina Cradle is designed to be an automatic detection device.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and software. The difference is in the addition of the Lamina Cradle which tracks the consumption of the reagent (provides visual warning flags and audio alerts).
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 (Attachment 1.0)
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 (Attachment 1.0 and 4.0)
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 (Page 3 of submittal letter)
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. (Page 3 of submittal letter)

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

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.