DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC

K120977 · International Technidyne Corp. · GGN · Jul 3, 2013 · Hematology

Device Facts

• Record ID: K120977
• Device Name: DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC
• Applicant: International Technidyne Corp.
• Product Code: GGN · Hematology
• Decision Date: Jul 3, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

The directCHECK® Whole Blood ACT-LR Level 1 (normal) and ACT-LR Level 2 (abnormal) Controls are assayed lyophilized whole blood preparations intended for the quality control of quantitative coagulation test: HEMOCHRON® ACT-LR assay on the HEMOCHRON® Jr. Signature+ and HEMOCHRON® Signature Elite instruments. The directCHECK® Whole Blood ACT+ Level 1 (normal) and ACT+ Level 2 (abnormal) Controls are assayed lyophilized whole blood preparations intended for the quality control of quantitative coagulation test: HEMOCHRON® ACT+ assay on the HEMOCHRON® Jr. Signature+ and HEMOCHRON® Signature Elite instruments.

Device Story

directCHECK® Whole Blood Controls are assayed, lyophilized non-human whole blood preparations (plasma and red blood cells) used for quality control of point-of-care coagulation testing. The device consists of a squeezable dropper containing liquid diluent and a glass ampoule with a lyophilized pellet. Operation involves squeezing the dropper to break the internal ampoule, mixing by inversion, and dispensing drops onto the sample port of a HEMOCHRON® test cuvette. The device is used by clinicians to verify the integrity and performance of HEMOCHRON® Jr. Signature+ and Signature Elite instruments. By providing a known control sample, it ensures the accuracy of quantitative coagulation assays, aiding in clinical decision-making for patients undergoing anticoagulation therapy.

Clinical Evidence

No clinical data. Bench testing only. Precision testing per CLSI EP5-A2 showed CVs of 14% and 10% for ACT-LR controls, and 10% and 5% for ACT+ controls, meeting acceptance criteria (≤14% and ≤12% respectively). Stability testing per CLSI EP25-A confirmed 5-month shelf-life and 4-week room temperature stability.

Technological Characteristics

Lyophilized whole blood (animal plasma/RBCs) in 1 mL glass ampoules with internal diluent (calcium chloride). Single-use. Storage 2-8°C. Analyzers use celite-activated intrinsic pathway clot detection. Standards referenced: CLSI EP05-A2, EP17-A, EP25-A.

Indications for Use

Indicated for quality control of quantitative coagulation tests (ACT-LR and ACT+ assays) on HEMOCHRON® Jr. Signature+ and Signature Elite instruments. 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.

Predicate Devices

• Hemochron® Jr. Microcoagulation ACT-Long Range Whole Blood Controls (k960749)
• Hemochron® Jr. Microcoagulation ACT+ Whole Blood Controls (k941007)

Submission Summary (Full Text)

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### SECTION 5: 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

JUL 0 3 2013

#### [A] 807.92 (a)(1): Submitter

- International Technidyne Corporation Name: 23 Nevsky Street Edison, NJ 08820 Address: [phone], FAX: [phone] Phone: Larry Picciano, Director of Regulatory Affairs Contact:
### [B] 807.92 (a)(2): Device name - Trade Name and Common Name, and Classification

directCHECK® Whole Blood Control for HEMOCHRON® ACT+ assay Trade name: directCHECK® Whole Blood Control for HEMOCHRON® ACT-LR assay Trade name: Common Name: Whole blood controls for in vitro diagnostic coagulation systems Classification: Class II, 21 CFR § 864.5425 Product Code: GGN, Plasma, Coagulation Control

#### [C] 807.92 (a) (3): Identification of the Legally Marketed Predicate Devices

Trade name: HEMOCHRON® Jr. Microcoagulation Low Range ACT including whole blood controls Normal / Abnormal

510(k) number: K960749

Manufacturer: International Technidyne Corporation (ITC), Edison, NJ

HEMOCHRON® Jr. Microcoagulation ACT+ test cuvette including whole Trade name: blood controls Normal / Abnormal

510(k) number: K941007

Manufacturer: International Technidyne Corporation (ITC), Edison, NJ

#### [D] 807.92 (a)(4): Device Description

The directCHECK® Whole Blood Controls are assayed lyophilized whole blood preparations intended for the quality control of quantitative coagulation tests. The directCHECK® whole blood control material is prepared from animal plasmas to which fixed animal red blood cells have been added. No human-based materials are contained in directCHECK® Whole Blood Controls. The whole blood control material is lyophilized in glass ampoules, and placed into an individual assembly with liquid diluent. When the glass ampoule is broken (activation of the assembly), the diluent rehydrates the lyophilized material, forming a liquid whole blood control.

#### [E] 807.92 (a)(5): Intended Use

The directCHECK® Whole Blood ACT-LR Level 1 (normal) and ACT-LR Level 2 (abnormal) Controls are assayed lyophilized whole blood preparations intended for the quality control of quantitative coagulation test: HEMOCHRON® ACT-LR assay on the HEMOCHRON® Jr. Signature+ and HEMOCHRON® Signature Elite instruments.

The directCHECK® Whole Blood ACT+ Level 1 (normal) and ACT+ Level 2 (abnormal) Controls are assayed lyophilized whole blood preparations intended for the quality control of quantitative coagulation test: HEMOCHRON® ACT+ assay on the HEMOCHRON® Jr. Signature+ and HEMOCHRON® Signature Elite instruments.

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## [G] 807.92 (a) (6): Technological Similarities and Differences to the Predicate

Each of the controls included in this submission has a unique predicate device as described in the tables below. For the directCHECK® Whole Blood Controls for HEMOCHRON® ACT-LR assay, the predicate device is HEMOCHRON® Jr. Microcoagulation Low Range ACT including whole blood controls cleared under 510(k) # K960749. Both products are two-level assayed whole blood controls used to monitor the integrity of point-of-care activated clotting time testing.

| | MODIFIED DEVICE: | PREDICATE DEVICE: |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CHARACTERISTIC | directCHECK® Whole Blood<br>Controls for HEMOCHRON® ACT-<br>LR Assay<br>K120977 | HEMOCHRON® Jr.<br>Microcoagulation Low Range ACT,<br>JQC-ACT-LR<br>K960749 |
| Intended Use | The directCHECK® Whole Blood ACT-<br>LR Level 1 (normal) and ACT-LR Level<br>2 (abnormal) Controls are assayed<br>lyophilized whole blood preparations<br>intended for the quality control of<br>quantitative coagulation test:<br>HEMOCHRON® ACT-LR assay on the<br>HEMOCHRON® Jr. Signature+ and<br>HEMOCHRON® Signature Elite<br>instruments. | The HEMOCHRON® Jr.<br>Microcoagulation Whole Blood<br>Controls are lyophilized whole blood<br>preparations which have been assayed<br>and are intended to be used to perform<br>quality control assays using the<br>HEMOCHRON® Jr. Microcoagulation<br>ACT-LR test cuvettes. |
| Material Composition | Non-human plasma, non-human red blood<br>cells and diluent (containing calcium<br>chloride). | Non-human plasma, non-human red<br>blood cells, diluent and calcium<br>chloride. |
| Form | Ready to use squeezable dropper<br>containing liquid diluent and glass<br>ampoule which contains lyophilized<br>pellet. | Three vials: lyophilized control, diluent,<br>and calcium chloride. |
| Storage | 2 to 8°C | 2 to 8° C non-punctured vials |
| Open Vial Claim | N/A, single-use, disposable, use<br>immediately. | May be kept at room temperature for a<br>maximum of one hour. |
| Procedural Steps | 1) Squeeze dropper to break glass<br>ampoule inside<br>2) Mix thoroughly by repeated inversion<br>3) Dispense first drop into cap<br>4) Dispense second drop onto the sample<br>port of the cuvette | 1) Dispense diluent into control vial via<br>syringe and swirl to rehydrate<br>2) Stabilize at room temperature for 15<br>minutes then swirl to dissolve<br>3) Add calcium chloride via syringe and<br>agitate end to end<br>4) Draw sample into syringe and<br>dispense onto the sample port of the<br>cuvette |
| Analyte | ACT-LR | ACT-LR |
| CHARACTERISTIC | MODIFIED DEVICE:<br>directCHECK® Whole Blood<br>Controls for HEMOCHRON® ACT+<br>Assay<br>K1210977 | PREDICATE DEVICE:<br>HEMOCHRON®<br>Microcoagulation Activated Clotting<br>Time PLUS (ACT+) test, QC-ACT+<br>K941007 |
| Intended Use | The directCHECK® Whole Blood ACT+<br>Level 1 (normal) and ACT+ Level 2<br>(abnormal) Controls are assayed<br>lyophilized whole blood preparations<br>intended for the quality control of<br>quantitative coagulation test:<br>HEMOCHRON® ACT+ assay on the<br>HEMOCHRON® Jr. Signature+ and<br>HEMOCHRON® Signature Elite<br>instruments. | The ACT+ Quality Control Product is a<br>lyophilized whole blood preparation<br>that is used to perform a quality control<br>assay using the HEMOCHRON® Jr.<br>Microcoagulation' ACT+ test cuvette. |
| Material Composition | Non-human plasma, non-human red blood<br>cells and diluent (containing calcium<br>chloride). | Non-human plasma, non-human red<br>blood cells, diluent and calcium<br>chloride. |
| Form | Ready to use squeezable dropper<br>containing liquid diluent and glass<br>ampoule which contains lyophilized<br>pellet. | Three vials: lyophilized control, diluent,<br>and calcium chloride. |
| Storage | 2 to 8°C | 4 to 8°C non-punctured vials |
| Open Vial Claim | N/A, single-use, disposable, use<br>immediately | May be kept at room temperature for a<br>maximum of one hour. |
| Procedural Steps | 1) Squeeze dropper to break glass<br>ampoule inside<br>2) Mix thoroughly by repeated inversion<br>3) Dispense first drop into cap<br>4) Dispense second drop onto the sample<br>port of the cuvette | 1) Dispense diluent into control vial via<br>syringe and swirl to rehydrate<br>2) Stabilize at room temperature for 15<br>minutes then swirl to dissolve<br>3) Add calcium chloride via syringe and<br>agitate end to end<br>4) Draw sample into syringe and<br>dispense onto the sample port of the<br>cuvette |
| Analyte | ACT+ | ACT+ |

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The predicate device for the directCHECK® Whole Blood Controls for HEMOCHRON® ACT+ assay, is the HEMOCHRON® Jr. Microcoagulation ACT+ test cuvette including whole blood controls cleared in 510(k) # K941007. Both products are two-level assayed Whole Blood Controls used to monitor the integrity of point-of-care activated clotting time testing.

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#### Conclusion

Based on the product comparisons and the data provided in this submission, both the directCHECK® Whole Blood Quality Controls for the HEMOCHRON® ACT-LR assay and the directCHECK® Whole Blood Quality Controls for the HEMOCHRON® ACT+ assay are substantially equivalent to K960749 and K941007 respectively.

#### [H] 807.92 (b)(1): Brief Description of Nonclinical Data

Precision testing was performed according to CLSI Guideline EP5-A2. The directCHECK® Whole Blood Controls for HEMOCHRON® ACT-LR assay overall CV for Level 1 is 14%: this satisfies the Level 1 criteria of ≤14%. The overall CV for Level 2 is 10%; this satisfies the Level 2 acceptance criteria of CV</2%. The directCHECK® Whole Blood Controls for HEMOCHRON® ACT+ assay overall CV for Level 1 is 10%, the overall CV for Level 2 is 5%. This performance satisfies the acceptance criteria for each level at CV ≤12%.

Stability was evaluated following principles in CLSI Guideline EP25-A. Real time stability test results for the directCHECK® for the HEMOCHRON® ACT-LR assay demonstrates 5 months of shelf-life for Level 1 and for Level 2. Real time stability test results for directCHECK® for the HEMOCHRON® ACT+ assay demonstrates 5 months shelf-life for Level 1 and Level 2.

Room temperature stability was evaluated following principles in CLSI Guideline EP25-A. Room temperature test results for Level 1 and for Level 2 directCHECK® for the HEMOCHRON® ACT-LR assay and for the HEMOCHRON® ACT+ assay each demonstrate 4 weeks. These results support the labeled room temperature claim.

#### JI] 807.92 (b)(2): Brief Description of Clinical Data

This section is not applicable as clinical studies were not performed and there are no clinical data in this 510(k).

#### [J] 807.92 (b)(3): Conclusions from Nonclinical and Clinical Testing

Nonclinical test results including precision, shelf-life (stability) study, and room temperature (storage) test results for the directCHECK® Whole Blood Controls for HEMOCHRON® ACT-LR assay and for the directCHECK® Whole Blood Controls for HEMOCHRON® ACT+ assay are acceptable indicating the modified product is substantially equivalent to the predicate, as well as being safe and effective for its intended use.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

JULY 3, 2013

INTERNATIONAL TECHNIDYNE INC C/O MR. LARRY PICCIANO DIRECTOR REGUALTORY AFFAIRS 23 NEVESKY ST. EDISON. NJ. 08820

Re: k120977

Trade/Device Name: directCHECK® for Hemochron Jr. Microcoagulation Systems ACT+

test cuvette

directCHECK® for Hemochron Jr. Microcoagulation Systems ACT-LR test cuvette

Regulation Number: 21 CFR 864.5425

Regulation Name: Multipurpose system for in vitro coagulation Regulatory Class: Class II

Product Code: GGN Dated: June 26, 2013

Received: June 27, 2013

Dear Mr. Picciano:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above 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, and Cosmetic Act (Act) that do not require 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class !II (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 that FDA has made 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

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Page 2 -- Mr. Larry Picciano

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Maria M. Chan -S

Maria M. Chan, Ph.D.

Director

Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological l-lealth

Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K120977

Device Name: directCHECK® Whole Blood ACT+ directCHECK® Whole Blood ACT-LR

Indications for Use:

The directCHECK® Whole Blood ACT+ Level 1 (normal) and ACT+ Level 2 (abnormal) Controls are assayed lyophilized whole blood preparations intended for the quality control of quantitative coagulation test: HEMOCHRON® ACT+ assay on the HEMOCHRON® Jr. Signature+ and HEMOCHRON® Signature Elite instruments.

The directCHECK® Whole Blood ACT-LR Level 1 (normal) and ACT-LR Level 2 (abnormal) Controls are assayed lyophilized whole blood preparations intended for the quality control of quantitative coagulation test: HEMOCHRON® ACT-LR assay on the HEMOCHRON® Jr. Signature+ and HEMOCHRON® Signature Elite instruments

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)

# Maria M. Chan -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k): k120977