ACL TOP 700 LAS

• 7 recalls, same reason

  • Terminated Z-2066-2014 FDA Class II ·initiated 3 Jun 2014
  • Terminated Z-2061-2014 FDA Class II ·initiated 3 Jun 2014
  • Terminated Z-2062-2014 FDA Class II ·initiated 3 Jun 2014
  • Terminated Z-2064-2014 FDA Class II ·initiated 3 Jun 2014
  • Terminated Z-2060-2014 FDA Class II ·initiated 3 Jun 2014
  • Terminated Z-2065-2014 FDA Class II ·initiated 3 Jun 2014
  • Terminated Z-2063-2014 FDA Class II ·initiated 3 Jun 2014

  Potential for sample misidentification.

• 7 recalls, same reason

  • Terminated Z-2246-2013 FDA Class II ·initiated 19 Jul 2013
  • Terminated Z-2250-2013 FDA Class II ·initiated 19 Jul 2013
  • Terminated Z-2249-2013 FDA Class II ·initiated 19 Jul 2013
  • Terminated Z-2244-2013 FDA Class II ·initiated 19 Jul 2013
  • Terminated Z-2248-2013 FDA Class II ·initiated 19 Jul 2013
  • Terminated Z-2245-2013 FDA Class II ·initiated 19 Jul 2013
  • Terminated Z-2247-2013 FDA Class II ·initiated 19 Jul 2013

  Potential carryover issue that can can cause shortened APTT clotting times on the instrument.

• 6 recalls, same reason

  • Terminated Z-2387-2012 FDA Class II ·initiated 3 Aug 2012
  • Terminated Z-2388-2012 FDA Class II ·initiated 3 Aug 2012
  • Terminated Z-2392-2012 FDA Class II ·initiated 3 Aug 2012
  • Terminated Z-2390-2012 FDA Class II ·initiated 3 Aug 2012
  • Terminated Z-2389-2012 FDA Class II ·initiated 3 Aug 2012
  • Terminated Z-2391-2012 FDA Class II ·initiated 3 Aug 2012

  Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low

• 4 recalls, same reason

  • Terminated Z-0135-2011 FDA Unclassified (pre-2012) ·initiated 13 Aug 2010
  • Terminated Z-0136-2011 FDA Unclassified (pre-2012) ·initiated 13 Aug 2010
  • Terminated Z-0137-2011 FDA Unclassified (pre-2012) ·initiated 13 Aug 2010
  • Terminated Z-0138-2011 FDA Unclassified (pre-2012) ·initiated 13 Aug 2010

  Software: New data check, "Multiple Threshold Check", was added to identify and fail abnormal (bimodal) clot curves

510(k) Number

K091980 ↗

FDA product code

GKP

Device class

Class II

Regulation

21 CFR Part 864.5400

Advisory committee

Hematology

FDA decision

SESE Substantially Equivalent

• HemosIL Silica Clotting Time

  Class II

  FDA 510(k) K253957 Active Cleared 9 Jan 2026

• GEM Premier 5000 PAK BG/COOX/TBILI 150 TEST 00055415005 Open recall

  Class II

  FDA 510(k) ×4 Active Cleared 14 Dec 2016 GUDID on market

• GEM CVP (Calibration Validation Product) Level 4 00024001814

  Class I

  CE/IVDR IVDR 727804 Active Valid to Oct 2031 FDA 510(k) K052121 Active Cleared 21 Oct 2005 +1authorizations

• HemosIL RecombiPlasTin 2G (8 mL) 00020002950

  Class II

  CE/IVDR GUDID on market

• ChemSTAT Hematocrit Evaluator 1 00044000104

  Class II

  GUDID on market

• Coatest SP FVIII 82 4086 63

  Class II

  FDA 510(k) K042576 Active Cleared 2 Dec 2004 GUDID on market

See all devices from Instrumentation Laboratory Company →

• What types of coagulation tests can the ACL TOP 700 LAS perform, and how does this benefit laboratory workflows?

  The ACL TOP 700 LAS automates key hemostasis assays like prothrombin time (PT) and activated partial thromboplastin time (APTT), which are essential for diagnosing and monitoring coagulation disorders. Its design supports both front-loaded samples and automated line sampling, enabling a high-throughput capacity of up to 360 PT tests per hour. This flexibility and efficiency help streamline workflows in clinical hematology laboratories by reducing manual handling and accelerating test processing.

• Is the ACL TOP 700 LAS a single-use or reusable device, and what does this mean for maintenance and cost?

  The ACL TOP 700 LAS is a reusable instrument, meaning it is built for long-term use in laboratory settings. This design reduces per-test costs compared to disposable alternatives and allows for consistent performance over time, though it requires routine maintenance, calibration, and cleaning protocols to ensure accuracy and reliability. Reusability also aligns with sustainability goals for high-volume coagulation testing.

• What regulatory pathway was followed for FDA clearance of the ACL TOP 700 LAS, and what does this imply for its clinical use?

  The ACL TOP 700 LAS received FDA clearance via a 510(k) premarket notification (K091980) under Special Review in the Hematology advisory committee category. This classification indicates the device was determined to be substantially equivalent to a legally marketed predicate, ensuring it meets regulatory standards for safety and effectiveness as an automated coagulation analyzer. Clinicians can rely on this pathway as evidence of its compliance with U.S. medical device regulations for hemostasis testing.

• How does the ACL TOP 700 LAS accommodate different sample input methods, and what are the practical advantages?

  The ACL TOP 700 LAS supports two sample input methods: front-loaded samples (manual placement) and automated line sampling (continuous feeding). Front-loading offers flexibility for smaller batches or urgent tests, while automated line sampling optimizes throughput for high-volume workflows, reducing operator intervention. This dual capability helps laboratories balance efficiency with adaptability depending on daily demand.

• What medical specialty is primarily served by the ACL TOP 700 LAS, and why is this device relevant to that field?

  The ACL TOP 700 LAS is categorized under Hematology and is specifically designed for clinical laboratories specializing in coagulation studies. Its relevance lies in its ability to perform critical assays like PT and APTT, which are foundational for diagnosing bleeding disorders, monitoring anticoagulant therapy (e.g., warfarin), and evaluating liver function. This makes it indispensable for hematologists, transfusion medicine teams, and general clinical labs managing coagulation-related patient care.