STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER

K961579 · American Bioproducts Co. · GKP · Jul 10, 1996 · Hematology

Device Facts

• Record ID: K961579
• Device Name: STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
• Applicant: American Bioproducts Co.
• Product Code: GKP · Hematology
• Decision Date: Jul 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5400
• Device Class: Class 2

Intended Use

The STA Compact® instrument is a fully automated laboratory analyzer designed to perform tests which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

Device Story

Fully automated laboratory analyzer; performs clot-based and photometric coagulation assays. Input: patient samples and reagents. Operation: random access testing; automated sample handling, reagent delivery, analysis, and reporting. CPU manages instrument functions, patient results, quality control, and maintenance. Barcode-enabled reagent management; supports third-party reagents. Used in clinical laboratory settings by trained laboratory personnel. Output: coagulation test results. Benefit: walkaway system efficiency; aids diagnosis of coagulation disorders and anticoagulant therapy monitoring.

Clinical Evidence

Bench testing only; sample-to-sample carryover demonstrated at 0.05%.

Technological Characteristics

Automated multi-parametric analyzer; clot-based and photometric detection; random access; barcode-enabled reagent management; CPU-controlled; supports Diagnostica Stago and third-party reagents.

Indications for Use

Indicated for use in clinical laboratories to perform coagulation tests for diagnosing coagulation abnormalities or monitoring anticoagulant therapy in patients requiring such assessment.

Regulatory Classification

Identification

A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.

Special Controls

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

Predicate Devices

• STA® analyzer (K942117)

Submission Summary (Full Text)

{0}

AMERICAN BIOPRODUCTS COMPANY
Pre-Market 510(k) Notification
STA Compact® Automated Multi-Parametric Analyzer
Page 53 of 53
K961579

# IX. SAFETY AND EFFECTIVENESS SUMMARY

## JUL 10 1996

The STA Compact® instrument is a fully automated laboratory analyzer designed to perform tests which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy. Once samples and test reagents are loaded onto the instrument, sample handling, reagent delivery, analysis and reporting of test results are performed automatically, making the STA Compact® instrument a true walkaway system. A central processing unit controls instrument functions, including management of patient results, quality control, scheduling of instrument maintenance and workload organization.

The instrument utilizes Diagnostica Stago (France) reagents, and is open to adaptation of other reagents currently available from third-party manufacturers. Barcoding of test reagents, calibrators and controls facilitates their use on the system and makes reagent management simple. Manual entry of reagent information enables the use of non-barcoded reagents.

The instrument performs multiple test methodologies in random access (as selected by the user); these include clot-based tests and photometric assays at predetermined wavelengths.

Sample-to-sample carryover has been demonstrated to be very low, being of the order of 5/100th of 1% (i.e., 0.05%).

The STA Compact® instrument is substantially equivalent to the commercially available full-size STA® analyzer that received FDA 510(k) clearance under K942117.