# K091980: Acl Top 700 Las

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory CO
- Decided: Sep 22, 2009 after 83 days
- Product code: GKP (Instrument, Coagulation, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5400
- Recalls of this device: 24 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K002400 (2000). 4 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073377: Acl Top (with System Software V3.0.0), Instrumentation Laboratory CO (2008) Summary page 1.

## Most influential descendants
- K150877: Acl Top Family 50 Series: Acl Top 350 CTS; Acl Top 550 CTS; Acl Top 750; Acl Top 750 CTS; Acl Top 750 Las (2015), 3 descendants of its own
- K160276: Acl Top (Acl Top 700, Acl Top 700 CTS, Acl Top 700 Las, Acl Top 500 CTS, Acl Top 300 CTS) (2016), 2 descendants of its own
- K242127: ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS) (2024), 0 descendants of its own
- K233790: Acl Top 970 CL (2023), 0 descendants of its own
- K231031: ACL TOP Family 70 Series (2023), 0 descendants of its own

## Recalls of this device
- Jun 3, 2014 · Class II · Z-2061-2014: Potential for sample misidentification.
- Jun 3, 2014 · Class II · Z-2066-2014: Potential for sample misidentification.
- Jun 3, 2014 · Class II · Z-2064-2014: Potential for sample misidentification.
- Jun 3, 2014 · Class II · Z-2060-2014: Potential for sample misidentification.
- Jun 3, 2014 · Class II · Z-2063-2014: Potential for sample misidentification.
- Jun 3, 2014 · Class II · Z-2062-2014: Potential for sample misidentification.
- Jun 3, 2014 · Class II · Z-2065-2014: Potential for sample misidentification.
- Jul 19, 2013 · Class II · Z-2248-2013: Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
- Jul 19, 2013 · Class II · Z-2244-2013: Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
- Jul 19, 2013 · Class II · Z-2245-2013: Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
- Jul 19, 2013 · Class II · Z-2246-2013: Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
- Jul 19, 2013 · Class II · Z-2250-2013: Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
- Jul 19, 2013 · Class II · Z-2247-2013: Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
- Jul 19, 2013 · Class II · Z-2249-2013: Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
- Aug 3, 2012 · Class II · Z-2387-2012: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
- Aug 3, 2012 · Class II · Z-2388-2012: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
- Aug 3, 2012 · Class II · Z-2392-2012: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
- Aug 3, 2012 · Class II · Z-2390-2012: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
- Aug 3, 2012 · Class II · Z-2389-2012: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
- Aug 3, 2012 · Class II · Z-2391-2012: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
- Aug 13, 2010 · Not classified · Z-0135-2011: Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot curves
- Aug 13, 2010 · Not classified · Z-0137-2011: Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot curves
- Aug 13, 2010 · Not classified · Z-0136-2011: Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot curves
- Aug 13, 2010 · Not classified · Z-0138-2011: Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot curves

## Indications for use
The ACL TOP 700 LAS is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The system provides results for both direct hemostasis measurements and calculated parameters.

Source page: https://510kreport.com/device/K091980
Methodology: https://510kreport.com/methodology