HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM

K110031 · Instrumentation Laboratory CO · GIR · Aug 24, 2011 · Hematology

Device Facts

• Record ID: K110031
• Device Name: HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM
• Applicant: Instrumentation Laboratory CO
• Product Code: GIR · Hematology
• Decision Date: Aug 24, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8950
• Device Class: Class 1

Intended Use

The HemosIL dRVVT Screen and HemosIL dRVVT Confirm assays are qualitative in-vitro diagnostic products to aid in the detection of lupus anticoagulants in human citrated plasma by the diluted Russell's Viper Venom method, on the ACL TOP® Family. The HemosIL dRVVT Screen and HemosIL dRVVT Confirm assays are intended to evaluate patients who have unexplained prolonged APTT test results. The HemosIL dRVVT Screen and HemosIL dRVVT Confirm assays should be used in parallel as an integrated test for Lupus Anticoagulant detection.

Device Story

HemosIL dRVVT Screen and Confirm are in-vitro diagnostic reagents for detecting lupus anticoagulant (LA) in human citrated plasma. The system uses diluted Russell's Viper Venom (dRVVT) to activate factor X in the presence of calcium. The Screen reagent is phospholipid-poor, making it sensitive to LA; the Confirm reagent contains excess phospholipid to neutralize LA, shortening clotting times. Operated on ACL TOP Family analyzers by laboratory technicians. The device calculates a normalized ratio (NR) of clotting times (Screen/Confirm). An NR above the laboratory-established cut-off indicates potential anti-phospholipid antibodies. Results assist clinicians in evaluating patients with unexplained prolonged APTT, aiding in the diagnosis of LA-related disorders.

Clinical Evidence

Bench testing only. Precision studies (CLSI EP5-A2) showed %CV < 5%. Interference studies confirmed tolerance to heparin (≤ 1.0 IU/mL), hemoglobin, bilirubin, and triglycerides. Method comparison study (n=524 total samples across internal and 3 field sites) demonstrated high agreement (PPA/NPA ≥ 80%) with predicate. Matrix comparison (3.2% vs 3.8% citrate) and fresh vs. frozen sample stability studies met acceptance criteria.

Technological Characteristics

Reagents contain Russell's viper venom, phospholipids, calcium, and heparin inhibitor. Qualitative assay based on dRVVT clotting time normalization. Designed for use on ACL TOP Family analyzers. Shelf-life of at least 2 years at 2-8°C. No specific ASTM material standards cited.

Indications for Use

Indicated for qualitative detection of lupus anticoagulants in human citrated plasma for patients with unexplained prolonged APTT test results. Used on ACL TOP Family analyzers. Prescription use only.

Regulatory Classification

Identification

Russell viper venom reagent is a device used to determine the cause of an increase in the prothrombin time.

Predicate Devices

• HemosIL® LAC Screen and HemosIL® LAC Confirm (k990302)

Submission Summary (Full Text)

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## 510K SUMMARY

| A. | | 510(k) Number | K110031 | AUG 2 4 2011 |
|----|------------------------|---------------------------------------|--------------------------------------------------------|--------------|
| B. | | Purpose for<br>Submission | New product | |
| D. | | Measurand | Lupus anticoagulant | |
| F. | | Type of Test | Diluted Russell's venom clotting assay | |
| H. | | Applicant | Instrumentation Laboratory Co. | |
| J. | | Proprietary &<br>Established<br>Names | HemosIL® dRVVT Screen and HemosIL dRVVT Confirm Assays | |
| L. | Regulatory Information | | | |
| | 1. | Regulation section: | 21CFR §864.8950, Russell's viper venom reagent | |
| | 2. | Classification: | Class II | |
| | 3. | Product code: | GIR | |
| | 4. | Device classification name: | Reagent, Russell's Viper Venom | |

#### Intended Use H.

- Intended use(s): 1.
The HemosIL dRVVT Screen and HemosIL dRVVT Confirm assays are qualitative in-vitro diagnostic products to aid in the detection of lupus anticoagulants in human citrated plasma by the diluted Russell's Viper Venom method, on the ACL TOP® Family. The HemosIL dRVVT Screen and HemosIL dRVVT Confirm assays are intended to evaluate patients who have unexplained prolonged APTT test results The HemosIL dRVVT Screen and HemosIL dRVVT Confirm assays should be used in parallel as an integrated test for Lupus Anticoagulant detection.

- Indication(s) for use: 2.
Same

Special conditions for use statement(s):

For in-vitro diagnostic use only. For prescription use. HemosIL dRVVT Confirm is intended to be used in conjunction with HemosIL dRVVT Screen.

- 3. Special instrument requirements:
ACL TOP Family Analyzers

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# Device Description

DRVVT Screen and dRVVT Confirm are improved dRVVT reagents, intended to simplify and standardize the detection of Lupus Anticoagulant (LA) disorder in clinical chemistry evaluations. DRVVT Screen is poor in phospholipid, making it sensitive to LA. The additional amount of phospholipid in dRVVT Confirm neutralizes LA to give shorter clotting times.

Russell's viper venom, in the presence of calcium, directly activates factor X (in a test sample). DRVVT Screen and dRVVT Confirm are therefore unaffected by contact factor abnormalities, factor VII, VIII and IX deficiencies, or inhibitors. As a result, dRVVT Screen and dRVVT Confirm are more specific tests for the evaluation of LA than APTT.

#### Substantial Equivalence Information J.

- Predicate device name(s): HemosIL LAC Screen & LAC Confirm (self) 1.
- Predicate 510(k) number(s): K990302 2.
- Comparison with predicate: 3.

### Similarities

The applicants, HemosIL dRVVT Screen and HemosIL dRVVT Confirm (PNs 000200301500 & 00020301600 respectively) are Substantially Equivalent to their predicates, the HemosIL LAC Screen and HemosIL LAC Confirm (K990302).

| | Table of similarities: |
|--|------------------------|
| | |

| Item | Predicate Device | Applicant |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | HemosIL LAC Screen & LAC<br>Confirm | HemosIL dRVVT Screen & dRVVT<br>Confirm |
| K# | K990302 | K110031 |
| Indications<br>for Use | HemosiL LAC Screen and HemosIL<br>LAC Confirm are in vitro diagnostic<br>products for the detection of lupus<br>anticoagulants (a type of<br>phospholipid interfering antibody)<br>in human citrated plasma on the<br>ACL TOP Family. | The HemosIL dRVVT Screen and<br>HemosIL dRVVT Confirm assays<br>are qualitative in-vitro diagnostic<br>products to aid in the detection of<br>lupus anticoagulants in human<br>citrated plasma by the diluted<br>Russell's Viper Venom method, on<br>the ACL TOP® Family. The HemosIL<br>dRVVT Screen and HemosIL dRVVT<br>Confirm assays are intended to<br>evaluate patients who have<br>unexplained prolonged APTT test<br>results The HemosIL dRVVT<br>Screen and HemosIL dRVVT<br>Confirm assays should be used in<br>parallel as an integrated test for<br>Lupus Anticoagulant detection. |
| Sample Type | Citrated plasma | Same |

- l.

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| Item | Predicate Device | Applicant |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Reagent<br>composition | Russell's viper venom,<br>phospholipids, calcium and heparin<br>inhibitor | Same |
| Test Principle | LAC Screen and LAC Confirm are<br>improved dRVVT reagents,<br>intended to simplify and<br>standardize the detection of Lupus<br>Anticoagulant (LA) disorder in<br>clinical chemistry evaluations. LAC<br>Screen is poor in phospholipid,<br>making it sensitive to LA. The<br>additional amount of phospholipid<br>in LAC Confirm neutralizes LA to<br>give shorter clotting times.<br>Russell's viper venom, in the<br>presence of calcium, directly<br>activates factor X (in a test sample). | Same |

### Differences

The main difference between the applicant, HemosIL dRVVT Screen and dRVVT Confirm, and their predicates HemosIL LAC Screen and LAC Confirm, is that the applicants have improved stability as compared to their predicates.

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

No performance standard or FDA guidance has been established for these reagents.

#### L. Test Principle

In dRVVT screening assays, a low, rate-limiting concentration of phospholipid is used to give a clotting time which is sensitive to the presence of lupus anticoagulants, since anti-phospholipid antibodies interfere with the clot-promoting role of phospholipid in vitro. A prolonged clotting time of a patient sample that does not correct with the addition of an equal volume of normal plasma suggests the presence of a lupus anticoagulant.

An abnormal result for the initial dRVVT screening assay should be followed by a dRVVT confirmatory test. In this test, the inhibitory effect of lupus anticoagulants on phospholipids in the dRVVT can be overcome by adding an excess of phospholipid to the assay.

The clotting times of both the initial dRVVT assay and confirmatory test are subsequently normalized and then used to determine a ratio: the time without phospholipid excess to time with phospholipid excess, the so called "normalized ratio". A ratio greater than the laboratory established cut-off is considered a positive result and implies that the patient may have anti-phospholipid antibodies.

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### Performance Characteristics

- Analytical performance 1.
- Precision/Reproducibility a.

Precision was assessed utilizing 3 lots of reagent on 3 representative members of the ACL TOP Family (ACL TOP and ACL TOP 500 CTS) by 3 independent operators. Precision was evaluated in accordance with CLSI EP05-A213, for 20 days, with 2 runs per day and 2 replicates per run for each sample level (n=80/ instrument/ lot), with the following results:

| ACL TOP Family | dRVVT NR |
|----------------------------|----------|
| LA Negative Control | 1.00 |
| Weakly LA Positive Control | 1.35 |
| LA Positive Control | 1.77 |

| HemosIL dRVVT NR | Within Run (%CV) | | | Between Run (%CV) | | | Total (%CV) | | |
|---------------------|------------------|-------|-------|-------------------|-------|-------|-------------|-------|-------|
| | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 | Lot 1 | Lot 2 | Lot 3 |
| LA Negative Control | 1.2 | 2.0 | 0.8 | 1.7 | 2.8 | 1.9 | 2.3 | 3.4 | 2.1 |
| Weakly LA Positive | 1.1 | 0.9 | 0.6 | 2.7 | 2.1 | 2.0 | 3.0 | 2.6 | 2.2 |
| LA Positive Control | 1.5 | 0.9 | 1.1 | 4.4 | 3.4 | 2.5 | 5.0 | 3.5 | 3.0 |

- Linearity/assay reportable range: NA, qualitative assay. b.
- C. Traceability, Stability, Expected values (controls, calibrators, or methods):

Unopened reagents are stable until the expiration date shown on the vial when stored at 2-8°C. Stability after reconstitution: 15 days at 2-8°C in the closed original vial or 3 days at 15°C in the original vials on the ACL TOP Family. dRVVT Screen/ Confirm may be used with either fresh or frozen samples. For optimal stability remove reagents from the system and store them, closed, at 2-8°C, in their original vials. Based on the results of the accelerated stability study, a shelf-life of at least 2 years is claimed for the products when stored at 2- 8°C. Real-time stability testing is ongoing, and will be used to update the shelf life as more data becomes available.

- Detection limit: NA d.
- Analytical specificity: e.

Interference studies were conducted on a representative member of the ACL TOP Family. Different concentrations of interferent were spiked into pooled normal plasma, weak LA Positive plasma and high LA Positive plasma The maximum concentration tolerated in the assay was defined as the highest concentration of interferent relative to the recovered value of the base clotting time ± 15%. The maximum tolerated concentrations not causing interference at any LA level tested were:

| Possible Interferant | Not affected by concentrations |
|-------------------------------------|--------------------------------|
| Unfractionated Heparin (UFH) | ≤ 1.0 IU/mL |
| Low Molecular Weight Heparin (LMWH) | ≤ 1.0 IU/m |
| Hemoglobin | ≤ 200 mg/dL |
| Bilirubin | ≤ 10 mg/dL |
| Triglyceride | ≤ 500 mg/dL |

M.

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Normalized dRVVT ratio higher than the internal-study cut-off (NR > 1.2) was found in the following plasma samples using dRVVT Screen/dRVVVT Confirm:

| Sample | ACL TOP Base | ACL TOP 500CTS |
|---------------------|--------------|----------------|
| Known LA Positive | 100% (35/35) | 100% (35/35) |
| Oral Anticoagulants | 40% (2/5) | 40% (2/5) |
| LMWH | 0% (0/5) | 0% (0/5) |
| UFH | 20% (1/5) | 0% (0/5) |
| DIC | 0% (0/5) | 0% (0/5) |
| Factor Deficiency | 0% (0/6) | 0% (0/6) |

#### f. Assay cut-off:

The Normalized Ratio cut off was determined as recommended using 40 normal healthy individual samples and calculating the Mean + 3SD. The results were obtained using a specific lot of reagent. Due to many variables which may affect results, each laboratory should establish its own NR cut off.

| System | Normalized dRVVT Ratio Cut Off |
|----------------|--------------------------------|
| ACL TOP | >1.2 |
| ACL TOP 500CTS | >1.2 |

#### Comparison studies: 2.

- a. An in-house method comparison was performed in accordance with EP09-A244, on 115 samples (80 Normal/ 35 known LA Positive), on a representative member of the ACL TOP Family (ACL TOP Base & ACL TOP 500 CTS). The Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) were calculated with the following result(s):

| Cut-Off<br>(Mean+3SD) | LAC<br>NR | dRVVT<br>NR | PPA | CI 95% | NPA | CI 95% | Overall | Reference |
|-----------------------|-----------|-------------|-------------------|-------------|-------------------|-------------|-------------------|------------------------|
| ACL TOP | > 1.2 | > 1.2 | 100.0%<br>(35/35) | 90.1-100.0% | 100.0%<br>(80/80) | 95.4-100.0% | 100%<br>(115/115) | LAC Screen/<br>Confirm |
| ACL TOP<br>500 CTS | > 1.2 | > 1.2 | 100.0%<br>(35/35) | 90.1-100.0% | 100.0%<br>(80/80) | 95.4-100.0% | 100%<br>(115/115) | |

Results were subsequently validated by 3 US field sites. Each site established its own cut-off, and validated that cut-off with 100+ samples, with the following result(s):

| Cut-Off<br>(Mean+3SD) | LAC<br>NR | dRVVT<br>NR | PPA | CI 95% | NPA | CI 95% | Overall | Reference |
|-----------------------|-----------|-------------|------------------|------------|-------------------|-------------|--------------------|------------------------|
| Site 1 | > 1.2 | > 1.2 | 92.7%<br>(38/41) | 80.6-97.5% | 98.9%<br>(91/92) | 94.1- 99.8% | 97%<br>(129/133) | LAC Screen,<br>Confirm |
| Site 2 | > 1.3 | > 1.3 | 90.2%<br>(46/51) | 79.0-95.7% | 98.9%<br>(91/92) | 94.1- 99.8% | 95.8%<br>137/143 | |
| Site 3 | > 1.3 | > 1.2 | 98.1%<br>(52/53) | 90.1-99.7% | 100.0%<br>(80/80) | 95.4-100.0% | 99.2%<br>(132/133) | |

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#### Matrix Comparison b.

A citrate study was performed to assess the effect on the assays of collecting the blood samples in 3.8% versus 3.2% sodium citrate sample tubes. Plasma from 26 donors was collected, in parallel, in both tube types. Artificial LA-Positive samples were prepared by spiking with different amounts of B2gPl antibodies to produce a range of concentrations. Using the previously established cut-off, the dRVVT Normalized Ratios for both 3.8% and 3.2% sodium citrate sample tubes were calculated. The two NRs were compared for their Positive and Negative Percent Agreement.

Results showed that the dRVVT Normalized Ratio on the ACL TOP is not affected by the type of citrate tubes used to draw blood samples.

| 3.8 v. 3.2% Na Citrate | PPA | CI 95% | NPA | CI 95% |
|------------------------|--------------|-----------|-------------|------------|
| ACL TOP | 19/19 (100%) | 83.2-100% | 24/26 (92%) | 75.9-97.9% |

A fresh v. frozen study was conducted to demonstrate that the results of fresh and frozen and once thawed samples are equivalent. Blood samples were drawn from 26 normal healthy donors. LA-Positive samples were prepared by spiking this pool with different amounts of ß2gPl antibodies. Fresh samples were kept at room temperature. Frozen samples were stored at -65℃ for 24 hr, prior to being thawed and analyzed at room temperature. Using the previously established cut-off, the dRVVT Normalized Ratios for both fresh and frozen (normal and LA-antibodies-spiked) samples were calculated. The two NRs were compared for their Positive and Negative Percent Agreement. The method comparison demonstrated that the dRVVT Normalized Ratio on the ACL TOP Family is not affected by whether the analysis is performed on fresh or frozen samples.

| Fresh vs. Frozen | PPA | CI 95% | NPA | CI 95% |
|------------------|--------------|------------|--------------|------------|
| ACL TOP | 28/28 (100%) | 87.9%-100% | 26/26 (100%) | 87.1%-100% |

- 3. Clinical Studies:
- a. Clinical Sensitivity: NA
- b. Clinical Specificity: NA
- C. Other clinical supportive data (when a. and b. are not applicable): NA
- Clinical cut-off: NA 4.
- 5. Expected values/Reference range:

A normal range study (n=120) was performed, in accordance with CLSI C28-A32, using dRVVT Screen/dRVVT Confirm on representative members of the ACL TOP Family. The following Reference intervals were established for dRVVT Screen, and for the dRVVT Screen/ Confirm Normal Ration (NR):

| | Normal Ratio Reference Interval (NR) | |
|-----------------|--------------------------------------|------------------|
| System | Lower Limit | Upper Limit |
| ACL TOP | 0.92 (0.91-0.93) | 1.11 (1.10-1.15) |
| ACL TOP 500 CTS | 0.91 (0.89-0.92) | 1.13 (1.11-1.16) |

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#### N. Proposed Labeling

The labeling is sufficient and 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.

#### P. Administrative Information

### Applicant Contact Information

| Name of applicant: | Instrumentation Laboratory Co. |
|--------------------|------------------------------------------------------|
| Mailing address: | 180 Hartwell Road<br>Bedford, MA 01730, USA |
| Phone #: | 781-861-4350 |
| Fax #: | 781-861-4207 |
| E-mail address: | [e-mail] |
| Contact: | Jacqueline Emery, BSEE<br>Regulatory Affairs Manager |
| Date Prepared | July 30, 2011 |

### Reference(s):

- 1. CLSI C28-A3: Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory, 30 edition.
- 2. Pengo V et al. Update of the Guidelines for Lupus Anticoagulant Detection. J. Thromb. Haem. 2009; 7:1737-1740.
- 3. Clinical and Laboratory Standards/CLSI. Establishment of Quantitative Measurement Procedures; Approved Guideline. Document EP5-A3: Vol. 0 No. 0.
- 4. Clinical and Laboratory Standards/CLSI. Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline. Document EP9-A2: Vol. 22 No.19.

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of a human figure, represented by flowing lines, with its arms outstretched.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Instrumentation Laboratory Co. c/o Ms. Jacqueline Emery Regulatory Affairs Manager 180 Hartwell Road Bedford. MA 01730

AUG 2 4 2011

Re: k110031

Trade/Device Name: HemosIL® dRVVT Screen and dRVVT Confirm Regulation Number: 21 CFR 864.8950 Regulation Name: Russell Viper Venom Test Regulatory Class: Class II Product Code: GIR, GGC Dated: August 16, 2011 Received: August 19, 2011

Dear Ms. Emery:

(

We have reviewed your Section 510(k) premarket notification of intent to market the device w & nave and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, do nots may been revire approval of a premarket approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, additional come of Enting may 2007 - 10 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I toase of a rised a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must of any I out all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket

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Page 2 - Ms. Jacqueline Emery

requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirents as set form in the quality of think (<=) (<=) (<= ) == ============================================================================================================ will anow you to begin marketing your antial equivalence of your device to a legally marketed nonication. The I Drice results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and II you desire specific advice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-807), prease condor the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDK regulation (27 Of RT LEV 807) products good gefault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Tou may oount only generarers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

ie m. elan

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510(k) Number (if known): K 11003|

Device Name: HemosIL® dRVVT Screen and HemosIL® dRVVT Confirm

### Indications for Use:

The HemosiL dRVVT Screen and HemoslL dRVVT Confirm assays are qualitative in-vitro diagnostic products to aid in the detection of lupus anticoagulants in human citrated plasma by the diluted Russell's Viper Venom method, on the ACL TOP® Family. The HemostL dRVVT Screen and HemosIL dRVVT Confirm assays are intended to evaluate patients who have unexplained prolonged APT test results The HemoslL dRVVT Screen and HemosIL dRVVT Confirm assays should be used in parallel as an integrated test for Lupus Anticoagulant detection.

Prescription Use __ V (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

mchan

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K110031