I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
Device Facts
| Record ID | K120900 |
|---|---|
| Device Name | I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 |
| Applicant | Cliniqa Corporation |
| Product Code | GGN · Hematology |
| Decision Date | May 31, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.5425 |
| Device Class | Class 2 |
Indications for Use
The i-STAT PT Control Level 1 (normal) and PT Control Level 2 (abnormal) are used for quality control of i-STAT PT cartridges on i-STAT handheld and wireless systems. The i-STAT ACT Control Level 1 (normal) and ACT Control Level 2 (abnormal) are used for quality control of i-STAT ACT cartridges on i-STAT handheld and wireless systems.
Device Story
Cliniqa i-STAT PT and ACT Controls are liquid, stabilized, human-based plasma products used as quality control materials for i-STAT coagulation cartridges. These controls are processed by laboratory personnel to verify the performance of i-STAT handheld and wireless systems. By testing these controls, clinicians ensure the accuracy and reliability of patient coagulation test results (PT and ACT) before performing diagnostic testing. The controls mimic normal and abnormal patient samples, allowing for the detection of potential system errors or cartridge degradation, thereby supporting clinical decision-making in coagulation management.
Clinical Evidence
No clinical data. Bench testing only. Precision and reproducibility studies conducted over 20 days across 3 sites using multiple instruments and operators. All results met pre-specified acceptance criteria (CV < 7.5%). Stability supported by real-time and accelerated studies using the Arrhenius equation to project shelf life.
Technological Characteristics
Lyophilized human plasma; reconstituted with 10mM CaCl2 solution. Analyte levels: PT (INR 1.2-3.0), ACT (80-800 seconds). Storage: 2-8°C. Compatible with Abbott i-STAT handheld/wireless systems. No electronic components; purely chemical control material.
Indications for Use
Indicated for quality control of i-STAT PT and ACT cartridges on i-STAT handheld and wireless systems. Intended for professional use in clinical settings.
Regulatory Classification
Identification
A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
Special Controls
*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
Related Devices
- K981752 — I-STAT COAGULATION CONTROL SET · Biopool Intl., Inc. · Jun 15, 1998
- K071319 — I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02 · Bio-Rad, Diagnostics Grp. · Jun 26, 2007
- K062306 — PLASMACON N, PLASMACON L-1, PLASMACON L-2 · R2 Diagnostics, Inc. · Mar 16, 2007
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
A. 510(k) Number:
k120900
B. Purpose for Submission:
To obtain clearance for control material for the PT and ACT assays run on the Abbott i-STAT handheld and wireless Clinical Analyzers.
C. Measurand:
Prothrombin Time (PT)
Activated Clotting Time (ACT)
D. Type of Test:
Quantitative clotting assay
E. Applicant:
Cliniqa Corporation
F. Proprietary and Established Names:
Cliniqa Coagulation Control Set
G. Regulatory Information:
1. Regulation section:
21 CFR 864.5425, Multipurpose system for in vitro coagulation studies
2. Classification:
Class II
3. Product code:
GGN, Plasma, Coagulation Control
4. Panel:
Hematology (81)
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H. Intended Use:
1. Intended use(s):
The i-STAT PT Control Level 1 (normal) and PT Control Level 2 (abnormal) are used for quality control of i-STAT PT cartridges on i-STAT handheld and wireless systems.
The i-STAT ACT Control Level 1 (normal) and ACT Control Level 2 (abnormal) are used for quality control of i-STAT ACT cartridges on i-STAT handheld and wireless systems.
2. Indication(s) for use:
Same as Intended use
3. Special conditions for use statement(s):
For prescription use only
4. Special instrument requirements:
For use with Abbott i-STAT® handheld and wireless systems
I. Device Description:
Cliniqa i-STAT® PT Control Level 1 - The PT Control Level 1 is produced from a pool of normal human plasma. After addition of buffer, the pool is aliquotted into 1mL portions. The aliquots are lyophilized, stoppered and capped. The lyophilized plasma is reconstituted with the supplied CaCl₂ solution prior to use.
Cliniqa i-STAT® PT Control Level 2 - The PT Control Level 2 is made from mixing pools of normal human plasma with factor depleted human plasma to yield a target INR between 2-3. The mixture is dispensed into vials in 1mL portions, lyophilized, stoppered and capped. The lyophilized plasma is reconstituted with the supplied CaCl₂ solution prior to use.
Cliniqa i-STAT® ACT Control Level 1 - The ACT Control Level 1 is produced from a pool of normal human plasma. After addition of buffer, the pool is aliquotted into 1mL portions. The aliquots are lyophilized, stoppered and capped. The lyophilized plasma is reconstituted with the supplied CaCl₂ solution prior to use.
Cliniqa i-STAT® ACT Control Level 2 - The ACT Control Level 2 is made from mixing pools of normal human plasma with factor depleted human plasma to yield a target clotting time between 400-800 seconds. The mixture is dispensed into vials in 1mL portions, lyophilized, stoppered and capped. The lyophilized plasma is
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reconstituted with the supplied $\mathrm{CaCl}_2$ solution prior to use.
Calcium Chloride Solution - The solution contains $10\mathrm{mM}\pm 2\mathrm{mM}$ $\mathrm{CaCl}_2$ , which is aliquotted into vials and capped.
# J. Substantial Equivalence Information:
1. Predicate device name(s): Biopool International, Inc. i-STAT® coagulation control set
2. Predicate 510(k) number(s): k981752
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | The i-STAT PT Control Level 1 (normal) and PT Control Level 2 (abnormal) are used for quality control of i-STAT PT cartridges on i-STAT handheld and wireless systems.The i-STAT ACT Control Level 1 (normal) and ACT Control Level 2 (abnormal) are used for quality control of i-STAT ACT cartridges on i-STAT handheld and wireless systems. | The i-STAT Activated Partial Thromboplastin (aPTT), Prothrombin Time (PT) and Activated Clotting Time (ACT) Controls are intended to be used with the i-STAT portable Clinical Analyzer and i-STAT aPTT, PT, and ACT test cartridges to provide a method for verifying the integrity of newly received cartridges. |
| Matrix | Human Plasma | Same |
| Physical Form | Lyophilized | Same |
| Shelf Storage | 2-8°C | Same |
| Reconstituted Stability | Immediate use | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Reagents and Systems | Abbott i-STAT® handheld and wireless systems PT and ACT reagents | Abbot i-STAT® handheld system PT, ACT and aPTT reagents |
| Analytes | PT (seconds, INR) Clotting time (seconds) | PT (seconds); Clotting time (seconds); aPTT (seconds) |
| Target Values | PT Level 1: 1.2-1.5 INR PT Level 2: 2.0-3.0 INR ACT Level 1: 80-200 sec ACT Level 2: 400-800 sec | PT Normal: 10.3-12.9 sec. PT Abnormal: 17.2-36.4 sec. ACT Normal: 94-152 sec. ACT Abnormal: 198-531 sec. aPTT Normal: 24.1-33.7 sec. aPTT Abnormal: 48.2-147.9 sec. |
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K. Standard/Guidance Document Referenced (if applicable):
Not applicable
L. Test Principle:
The controls are used for verification of the newly received i-STAT® PT and ACT cartridges. The controls are meant to test performance of the test strips by comparing the measurements the controls produced with the i-STAT® cartridges with a target values and ranges previously assigned to the controls. Instructions are outlined in the i-STAT system manual for the user to follow if results fall outside the range.
M. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Within-site repeatability was determined for 3 lots of each control level. Testing was performed twice a day, in duplicate, using two instruments over a period of 20 non-consecutive testing days. The %CV for each lot combined for both instruments met the pre-specified acceptance criteria of CV<7.5%. The acceptance criteria of %CV<7.5% for the ACT was also met. A further analysis for variability introduced by the two instruments used in the repeatability study, determined that the instrument-to-instrument variability observed in this study also met the acceptance criteria of %CV<7.5%.
Please see the table below for a summary of results.
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| | | Precision | Seconds | INR |
| --- | --- | --- | --- | --- |
| PT Control Level 1 | Lot 1 | Instrument to Instrument | Mean 14.95s
SD 0.07
0.4%CV | Mean 1.26
SD 0.014
1.1 %CV |
| Total | Mean 14.92s
SD 0.47
3.2%CV | Mean 1.3
SD 0.055
4.3 %CV |
| Lot 2 | Instrument to Instrument | Mean 13.96s
SD 0.007
0.05%CV | Mean 1.17
SD 0
0%CV |
| Lot 3 | Instrument to Instrument | Mean 14.0s
SD 0.47
3.4%CV | Mean 1.3
SD 0.058
4.6 %CV |
| Total | Mean 14.35s
SD 0.07
0.5%CV | Mean 1.21
SD 0.014
1.1 %CV |
| Lot 2 | Instrument to Instrument | Mean 14.4s
SD 0.50
3.5%CV | Mean 1.21
SD 0.051
4.3 %CV |
| PT Control Level 2 | Lot 1 | Instrument to Instrument | Mean 23.75s
SD 0.14
0.06%CV | Mean 2.07
SD 0.05
2.4 %CV |
| Total | Mean 23.7s
SD 0.96
4.0%CV | Mean 2.0
SD 0.09
4.6 %CV |
| Lot 2 | Instrument to Instrument | Mean 23.1s
SD 0.28
1.2%CV | Mean 2
SD 0.08
0%CV |
| Lot 3 | Instrument to Instrument | Mean 23.1s
SD 0.83
3.6%CV | Mean 2.0
SD 0.08
4.0 %CV |
| Total | Mean 30.95s
SD 0.35
1.1%CV | Mean 2.7
SD 0
0 %CV |
| Total | Mean 31.0s
SD 1.08
3.5%CV | Mean 2.7
SD 0.10
3.7 %CV |
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| | | Precision | Celite | Kaolin |
| --- | --- | --- | --- | --- |
| ACT Control Level 1 | Lot 1 | Instrument to Instrument | Mean 188s
SD 0.14
0.1%CV | Mean 171
SD 1.4
0.8 %CV |
| | | Total | Mean 188s
SD 6.1
3.3%CV | Mean 171
SD 4.7
2.7 %CV |
| | Lot 2 | Instrument to Instrument | Mean 154s
SD 0.14
0.1%CV | Mean 146
SD 1.4
1%CV |
| | | Total | Mean 154s
SD 5.3
3.5%CV | Mean 146
SD 4.1
2.8 %CV |
| | Lot 3 | Instrument to Instrument | Mean 146s
SD 0.07
0.05%CV | Mean 128
SD 2.1
0.02 %CV |
| | | Total | Mean 146s
SD 5.2
3.6%CV | Mean 128
SD 4.6
3.6 %CV |
| ACT Control Level 2 | Lot 1 | Instrument to Instrument | Mean 550s
SD 2.8
1.00%CV | Mean 452
SD 4.2
0.9 %CV |
| | | Total | Mean 550s
SD 28.9
5.3%CV | Mean 452
SD 23.4
5.2 %CV |
| | Lot 2 | Instrument to Instrument | Mean 577s
SD 4.9
0.9%CV | Mean 471
SD 4.2
0.9%CV |
| | | Total | Mean 577s
SD 23
4.0%CV | Mean 471
SD 14.7
3.1 %CV |
| | Lot 3 | Instrument to Instrument | Mean 546s
SD 0.71
0.1%CV | Mean 453
SD 6.4
1.0 %CV |
| | | Total | Mean 545s
SD 25.4
4.7%CV | Mean 451
SD 25.2
5.6 %CV |
Reproducibility was assessed by daily testing at 3 sites over a period of five non-consecutive days. Each vial of control material was tested with two different instruments. Sites 1 and 2 included one operator and two instruments each, whereas site 3 included 3 operators and 10 instruments. Within-site and between-site variability met the pre-determined acceptance criteria of $\% \mathrm{CV} < 7.5$, as summarized in the tables below:
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| | Seconds | | | INR | | |
| --- | --- | --- | --- | --- | --- | --- |
| PT Control Level 1 | Mean 15.1 sec, 0.72 SD, 4.8%CV | | | Mean 1.28 INR, 0.08 SD, 6.0%CV | | |
| | Site 1
Mean 14.9s
0.14 SD
0.9 %CV | Site 2
Mean 14.7s
0.29 SD
2.0 %CV | Site 3
Mean 15.7s
0.75 SD
4.8 %CV | Site 1
Mean 1.3
0.02 SD
1.5 %CV | Site 2
Mean 1.2
0.04 SD
3.3 %CV | Site 3
Mean 1.3
0.07 SD
5.4 %CV |
| PT Control Level 2 | Mean 23.9 sec, 0.75 SD, 3.0%CV | | | Mean 2.1 INR, 0.07 SD, 3.50%CV | | |
| | Site 1
Mean 24.2s
0.38 SD
1.6 %CV | Site 2
Mean 23.7s
0.34 SD
1.4 %CV | Site 3
Mean 23.9s
2.1 SD
0.34%CV | Site 1
Mean 2.1
0.07 SD
3.3 %CV | Site 2
Mean 2.1
0.05 SD
2.4 %CV | Site 3
Mean 2.1
0.05 SD
2.4 %CV |
| | Celite | | | Kaolin | | |
| --- | --- | --- | --- | --- | --- | --- |
| ACT Control Level 1 | Mean 156, 5.3 SD, 3.5%CV | | | Mean 148, 3.9 SD, 2.6%CV | | |
| | Site 1
Mean 152s
3.79 SD
2.5 %CV | Site 2
Mean 158s
3.68 SD
2.3 %CV | Site 3
Mean 158s
3.85 SD
2.4 %CV | Site 1
Mean 146s
1.96 SD
1.3 %CV | Site 2
Mean 151s
2.68 SD
1.8 %CV | Site 3
Mean 148s
3.03 SD
2.00 %CV |
| ACT Control Level 2 | Mean, 550, 29 SD, 5.3%CV | | | Mean 457, 17 SD, 3.7%CV | | |
| | Site 1
Mean 558s
15 SD
2.7 %CV | Site 2
Mean 564s
29 SD
5.2 %CV | Site 3
Mean 529s
17 SD
3.1 %CV | Site 1
Mean 455s
11 SD
2.4 %CV | Site 2
Mean 458s
14 SD
3.0 %CV | Site 3
Mean 458s
17 SD
3.7 %CV |
b. Linearity/assay reportable range:
Not applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Value assignment:
The value assignment testing is performed by Abbot Pont of Care (APOC). The target values of control materials are based on 48 repeat measurements with the i-STAT PT or ACT assays with at minimum of 10 instruments for each control level. In addition to the value assignment testing, APOC further calculates the target and value ranges, and publishes the allowable value ranges on its website. Control fluid assignment ranges are set at fixed ranges around the acceptable CV of 7.5% and 10% for the PT and ACT, respectively.
Stability:
Real time stability studies are currently still ongoing. The stability claim is based on preliminary real time stability data available at time of clearance. One lot of control material each was tested at time zero and at multiple intermediate time points. These preliminary results met the predetermined acceptance criteria and therefore support the following shelf lives at refrigerated storage between 2°C and 8°C:
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| Control Material | Shelf-life data at time of clearance |
| --- | --- |
| PT Control Level 1 | 375 days |
| PT Control Level 2 | 300 days |
| ACT Control Level 1 | 375 days |
| ACT Control Level 2 | 375 days |
To further support the stability claim, accelerated stability studies were performed on 3 lots of control material at 45°C and 56°C to project a shelf life of 2 years at 4°C. In short, samples were stored at either 45°C or 56°C. Two vials of controls were tested each on day 0, 4, 8, 12, and 16 when stored at 45°C and day 0, 2, 4, 6, and 8 when stored at 56°C. Testing consisted of analysis with the Abbot i-STAT PT assay or both the Abbot i-STAT ACT Celite and Kaolin reagents. The Arrhenius equation was utilized to assess the rate of degradation. Days to failure were determined based on a limit of 10% degradation. Taken together, the accelerated stability data project a shelf life of 2 years at refrigerated storage for the PT control levels 1 and 2 as well as the ACT control levels 1 and 2.
d. Detection limit:
Not applicable
e. Analytical specificity:
Not applicable
f. Assay cut-off:
Not applicable
2. Comparison studies:
a. Method comparison with predicate device:
Not applicable
b. Matrix comparison:
Not applicable
3. Clinical studies:
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a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable
4. Clinical cut-off:
Not applicable
5. Expected values/Reference range:
Target values and ranges will be available on the Abbott Point of Care website (www.abbottpointofcare.com)
N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.
O. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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