ACTICLOT, MODEL 824

K052124 · American Diagnostica, Inc. · GJS · Oct 17, 2005 · Hematology

Device Facts

• Record ID: K052124
• Device Name: ACTICLOT, MODEL 824
• Applicant: American Diagnostica, Inc.
• Product Code: GJS · Hematology
• Decision Date: Oct 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7750
• Device Class: Class 2

Indications for Use

The ACTICLOT® dPT™ is intended for the qualitative determination of lupus anticoagulants (LA) in human plasma. This test is for in vitro diagnostic use.

Device Story

ACTICLOT® dPT™ is a reagent kit for qualitative detection of Lupus Anticoagulants (LA) in citrated human plasma. Kit includes dPT™ Activator (recombinant tissue factor), LA Buffer™, and LA Phospholipids™. Operates via two-step clotting assay: screening protocol (plasma + buffer + activator) and confirmatory protocol (plasma + phospholipids + activator). Performed on semi-automated or automated coagulation analyzers in clinical laboratory settings. Prolonged screening clot time indicates potential LA; significant reduction in confirmatory clot time confirms presence. Results assist clinicians in diagnosing LA-related coagulation disorders. Bypasses contact intrinsic pathway, excluding interference from Factor XI/XII deficiencies.

Clinical Evidence

Bench testing and method comparison studies performed. Precision evaluated across four coagulation analyzers (ACL 300R, BCT, MLA 900C, STA Compact) with intra-assay CVs 0.5-3.8% and inter-assay CVs 3.2-8.6%. Method comparison with predicate (n=143 samples across two sites) showed 87.6-90.7% agreement. Clinical sensitivity study (n=23 prescreened LA positive samples) showed 78.3% sensitivity, comparable to predicate (78.3%) and aPTT-based LA tests (82.6%). Interference testing confirmed no impact from heparin up to 1.0 U/mL; potential interference noted for lipemic, icteric, hemolysed samples and oral anticoagulants.

Technological Characteristics

Reagent kit containing recombinant tissue factor (dPT™ Activator), LA Buffer™, and LA Phospholipids™. Clotting assay based on extrinsic coagulation pathway activation. Compatible with semi-automated and automated coagulation analyzers. No specific materials of construction or connectivity standards specified.

Indications for Use

Indicated for the qualitative determination of lupus anticoagulants (LA) in human plasma for in vitro diagnostic use.

Regulatory Classification

Identification

A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).

Predicate Devices

• DVVtest® and DVVconfirm® (K940490)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K052124

B. Purpose for Submission:
Clearance of a new device

C. Analyte:
Lupus Anticoagulant

D. Type of Test:
Clotting

E. Applicant:
American Diagnostica

F. Proprietary and Established Names:
Acticlot® dPT™

G. Regulatory Information:
1. Regulation section:
21 CFR 864.7750
2. Classification:
Class II
3. Product Code:
GJS
4. Panel:
81 Hematology

H. Intended Use:
1. Intended use(s):
The ACTICLOT® dPT® is an in vitro diagnostic assay intended for the qualitative determination of Lupus Anticoagulants (LA) in human plasma.
2. Indication(s) for use:
3. Special condition for use statement(s):
4. Special instrument Requirements:

I. Device Description:
The ACTICLOT® dPT™ is a reagent kit. It has three reagents that are used selectively for a screening protocol and a confirmatory protocol. LA Buffer™ is used with dPT™ Activator for the screening protocol. LA Phospholipid™ is used with dPT™ Activator for the confirmatory protocol.

J. Substantial Equivalence Information:
1. Predicate device name(s):
DVVtest® and DVVconfirm®
2. Predicate K number(s):
K940490

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3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | For the qualitative determination of lupus anticoagulants (LA) in human plasma. | Same |
| Sample Requirements | Citrated plasma | Same |
| Differences | | |
| Item | Device | Predicate |
| Methodology | Clotting assay (PT) | Clotting assay (PTT) |
| Test Principle | In the screening protocol, dPT™ Activator (recombinant tissue factor) and calcium is mixed with LA Buffer™ to initiate clotting. Instrumentation is used to measure the clot time. IN the confirmatory protocol, the dPT™ Activator is mixed with the LA Phospholipids™ reagent, and instrumentation is used to determine the clot time. | Russell’s Viper Venom reagent in the DVVtest is used to initiate clotting in plasma and then instrumentation is used to measure the clot time. For the confirmation assay, Russell’s Viper Venom Reagent and phospholipids in the DVVconfirm is used to initiate clotting and then instrumentation is used to measure clot time. |

K. Standard/Guidance Document Referenced (if applicable):

L. Test Principle:

The ACTICLOT dPT is a coagulation assay that identifies the presence of LA in plasma. Clotting is initiated by activating the tissue factor (extrinsic) coagulation pathway with tissue factor in the presence of calcium ions. Tissue Factor binds to Factor VIIa resulting in the activation of Factor IX and Factor X. Factor Xa converts prothrombin to thrombin which initiates clot formation by cleaving fibrinogen to fibrin. Activation of the tissue factor pathway bypasses the activation of the contact intrinsic pathway and excludes any interference from deficiencies of Factors XI and XII.

In the Screening Protocol, the patient plasma is mixed with the ACTICLOT LA Buffer™ and ACTICLOT dPT Activator™. The clot time is determined by semi-automated or automated methods. A positive result is indicated by a prolonged clot time relative to an established normal range. In the Confirmatory Protocol, the patient plasma is mixed with the ACTICLOT LA Phospholipids™ and ACTICLOT dPT Activator. A positive result is indicated by a significant reduction of the clot time relative to the clot time in the screening protocol.

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Plasmas are identified as possessing LA when both the Screening and Confirmatory Protocols are performed and both tests are positive.

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

#### a. Precision/Reproducibility:

ACTICLOT dPT reagent precision studies were performed on two sites using LAtrol Normal Control, LAtrol™ Abnormal Control, and various coagulation analyzers: ACL® 300R centrifugal analyzer, BCT®, MLA® 900C coagulation analyzer, and the STA Compact®. Testing involved multiple runs over several days. Results are as follows:

TABLE 2. Precision Study Results with ACTICLOT® dPT™

| Coagulation Analyzer | Control | dPT Screening mean (sec) | Intra-Assay CV (%) | Inter-Assay CV (%) | dPT Confirmatory mean (sec) | Intra-Assay CV (%) | Inter-Assay CV (%) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| ACL® 300R | Normal | 32.8 | 2.5 | 5.1 | 30.2 | 3.8 | 5.3 |
| | Abnormal | 63.8 | 1.9 | 7.1 | 36.9 | 3.2 | 3.8 |
| BCT® | Normal | 47.5 | 0.5 | 3.2 | 51.6 | 1.7 | 4.5 |
| | Abnormal | 89.2 | 0.6 | 5.2 | 61.9 | 1.2 | 3.7 |
| MLA® 900C | Normal | 27.9 | 2.5 | 3.7 | 27.2 | 2.8 | 4.1 |
| | Abnormal | 51.6 | 2.4 | 8.6 | 30.5 | 1.5 | 3.7 |
| STA Compact® | Normal | 40.2 | 0.8 | 3.4 | 39.7 | 0.9 | 4.3 |
| | Abnormal | 77.9 | 1.1 | 7.2 | 46.0 | 1.0 | 4.8 |

#### b. Linearity/assay reportable range

#### c. Traceability (controls, calibrators, or method):

#### d. Detection limit:

#### e. Analytical specificity:

Testing demonstrated interference with lipemic, icteric and hemolysed samples.

Testing demonstrated no interference from unfractionated heparin up to and including 1.0 U/mL.

The ACTICLOT® dPT™ screening time may be prolonged in patients with congenital or acquired factor deficiencies. Eighteen known Factor Deficiency patient plasmas were tested with ACTICLOT® dPT

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and none tested positive for LA "neat" and/or with a 1:1 mix with pooled normal plasma.

Plasmas from patients treated with Coumadin and other oral anticoagulants may have prolonged ACTICLOT® dPT™ screening and confirmatory clot times.

f. Assay cut-off:

2. Comparison studies:

a. A. Method comparison with predicate device:

ACTICLOT® dPT™ Method comparison studies were performed two sites. Patient samples were tested using ACTICLOT® dPT™ and DVVtest® and DVVconfirm®.

Site 1

| | #samples LA pos with DVVtest® and DVVconfirm® | #samples LA neg with DVVtest® and DVVconfirm |
| --- | --- | --- |
| #samples LA pos with ACTICLOT® dPT™ | 17 | 5 |
| #samples LA pos with ACTICLOT® dPT™ | 0 | 32 |

49 out of 54 samples were in agreement (90.7%)

Site 2

| | #samples LA pos with DVVtest® and DVVconfirm® | #samples LA neg with DVVtest® and DVVconfirm |
| --- | --- | --- |
| #samples LA pos with ACTICLOT® dPT™ | 31 | 8 |
| #samples LA pos with ACTICLOT® dPT™ | 3 | 47 |

78 out of 89 samples were in agreement (87.6%)

b. Matrix comparison:

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3. Clinical studies:
a. Clinical sensitivity:

23 prescreened LA positive samples were tested at two sites with the predicate device, the subject device, and a third commercially available aPTT sensitive LA test.

Percent LA Positive Test Results from each of Three LA Tests

| | ACTICLOT® dPT™^{a} | DVVtest®/DVVconfirmb | aPTT reagent^{b} |
| --- | --- | --- | --- |
| Number of Samples that Tested LA Positive with One LA Test / Number of LA Positive Plasmas | 18/23 | 18/23 | 19/23 |
| Percent LA Positive | 78.3% | 78.3% | 82.6% |

(a) Assays were performed using the ACL 300R coagulation analyzer,
(b) Assays were performed using the Sysmex*CA-1500 coagulation analyzer.

b. Clinical specificity:

c. Other clinical supportive data (when a and b are not applicable):

4. Clinical cut-off:

5. Expected values/Reference range:

| Coagulation Analyzer | ACL® 300R (n=25) | BCT® (n=32) | CA7000 (n=20) | MLA® 900C <n=93) | ST4 (n=25) | STA Compact® (n=25) |
| --- | --- | --- | --- | --- | --- | --- |
| Screening Time (sec) | 34.4 ± 4.5 | 51.2 ± 7.8 | 38.8 ± 8.8 | 26.7 ± 4.8 | 38.4 ± 4.2 | 36.6 ± 5.9 |
| Confirmatory Time (sec) | 29.2 ± 4.8 | 50.5 ± 11.0 | 35.8±4.0 | 26.2 ± 5.2 | 34.9 ± 8.5 | 35.7 ± 3.1 |
| S/C Ratio | 1.18 ± 0.12 | 1.02 ± 0.12 | 1.08 ±0.26 | 1.02 ± 0.16 | 1.11 ±0.19 | 1.03 ±0.09 |

Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.