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.

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.

AI/ML Overview

The acceptance criteria and study proving device performance are described below based on the provided text.

Acceptance Criteria and Device Performance

Device: directCHECK® Whole Blood Control for HEMOCHRON® ACT+ assay and directCHECK® Whole Blood Control for HEMOCHRON® ACT-LR assay

Study Type: Non-clinical precision and stability testing. Clinical studies were not performed.

Acceptance Criteria	Reported Device Performance (directCHECK® ACT-LR assay)	Reported Device Performance (directCHECK® ACT+ assay)
Overall CV for Level 1 ≤ 14%	Overall CV for Level 1 is 14%	Overall CV for Level 1 is 10%
Overall CV for Level 2 ≤ 12%¹	Overall CV for Level 2 is 10%	Overall CV for Level 2 is 5%
Shelf-life Demonstrating 5 months of stability	5 months of shelf-life for Level 1 and Level 2	5 months of shelf-life for Level 1 and Level 2
Room temperature stability demonstrating 4 weeks	4 weeks for Level 1 and Level 2	4 weeks for Level 1 and Level 2

Note: The text explicitly states "this satisfies the Level 2 acceptance criteria of CV</2%." However, it then immediately follows with the ACT+ assay where Level 2 performance of 5% satisfies "acceptance criteria for each level at CV ≤12%." This suggests a potential typo in the ACT-LR Level 2 criteria, or different criteria were applied. Given the ACT+ Level 2 satisfaction at ≤12%, and 10% for ACT-LR Level 2, I have assumed the ≤12% applies to both as a reasonable interpretation of the overall statement. If the "<2%" was truly the criterion, the ACT-LR Level 2 (10%) would not have met it.

Additional Information:

Sample size used for the test set and the data provenance: This information is not explicitly provided in the document. The text mentions "Precision testing was performed according to CLSI Guideline EP5-A2" and "Stability was evaluated following principles in CLSI Guideline EP25-A," which are general guidelines. The specific number of samples or data provenance (e.g., country of origin, retrospective/prospective) is not detailed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a quality control material for coagulation tests. The "ground truth" for its performance is assessed via objective measurements of its characteristics (e.g., coefficient of variation, stability) against pre-defined analytical acceptance criteria, not through expert consensus on medical images or clinical outcomes.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as expert adjudication is not relevant for determining the performance of a quality control material. Performance is measured analytically.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a quality control material for in vitro diagnostic coagulation systems, not an AI-assisted diagnostic tool that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is a standalone quality control product; it does not involve an algorithm. Its performance is measured directly.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this quality control material is its intrinsic analytical properties, specifically its precision (measured by coefficient of variation, CV) and stability over time and under various storage conditions. These established analytical targets serve as the ground truth.
The sample size for the training set: Not applicable. This device is not an AI algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable.

The text has a potential discrepancy here. For the ACT-LR assay, it states "this satisfies the Level 2 acceptance criteria of CV</2%." However, Level 2 performance is 10%. For the ACT+ assay, Level 2 performance is 5% which "satisfies the acceptance criteria for each level at CV ≤12%." Given that 10% for ACT-LR Level 2 is "satisfied," it's highly probable the "<2%" was a typo, and the actual acceptance criterion for Level 2 was ≤12%. ↩

Summary

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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: (732) 548-5700, FAX: (732) 635-0144 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

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

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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 BloodControls for HEMOCHRON® ACT-LR AssayK120977	HEMOCHRON® Jr.Microcoagulation Low Range ACT,JQC-ACT-LRK960749
Intended Use	The directCHECK® Whole Blood ACT-LR Level 1 (normal) and ACT-LR Level2 (abnormal) Controls are assayedlyophilized whole blood preparationsintended for the quality control ofquantitative coagulation test:HEMOCHRON® ACT-LR assay on theHEMOCHRON® Jr. Signature+ andHEMOCHRON® Signature Eliteinstruments.	The HEMOCHRON® Jr.Microcoagulation Whole BloodControls are lyophilized whole bloodpreparations which have been assayedand are intended to be used to performquality control assays using theHEMOCHRON® Jr. MicrocoagulationACT-LR test cuvettes.
Material Composition	Non-human plasma, non-human red bloodcells and diluent (containing calciumchloride).	Non-human plasma, non-human redblood cells, diluent and calciumchloride.
Form	Ready to use squeezable droppercontaining liquid diluent and glassampoule which contains lyophilizedpellet.	Three vials: lyophilized control, diluent,and calcium chloride.
Storage	2 to 8°C	2 to 8° C non-punctured vials
Open Vial Claim	N/A, single-use, disposable, useimmediately.	May be kept at room temperature for amaximum of one hour.
Procedural Steps	1) Squeeze dropper to break glassampoule inside2) Mix thoroughly by repeated inversion3) Dispense first drop into cap4) Dispense second drop onto the sampleport of the cuvette	1) Dispense diluent into control vial viasyringe and swirl to rehydrate2) Stabilize at room temperature for 15minutes then swirl to dissolve3) Add calcium chloride via syringe andagitate end to end4) Draw sample into syringe anddispense onto the sample port of thecuvette
Analyte	ACT-LR	ACT-LR
CHARACTERISTIC	MODIFIED DEVICE:directCHECK® Whole BloodControls for HEMOCHRON® ACT+AssayK1210977	PREDICATE DEVICE:HEMOCHRON®Microcoagulation Activated ClottingTime PLUS (ACT+) test, QC-ACT+K941007
Intended Use	The directCHECK® Whole Blood ACT+Level 1 (normal) and ACT+ Level 2(abnormal) Controls are assayedlyophilized whole blood preparationsintended for the quality control ofquantitative coagulation test:HEMOCHRON® ACT+ assay on theHEMOCHRON® Jr. Signature+ andHEMOCHRON® Signature Eliteinstruments.	The ACT+ Quality Control Product is alyophilized whole blood preparationthat is used to perform a quality controlassay using the HEMOCHRON® Jr.Microcoagulation' ACT+ test cuvette.
Material Composition	Non-human plasma, non-human red bloodcells and diluent (containing calciumchloride).	Non-human plasma, non-human redblood cells, diluent and calciumchloride.
Form	Ready to use squeezable droppercontaining liquid diluent and glassampoule which contains lyophilizedpellet.	Three vials: lyophilized control, diluent,and calcium chloride.
Storage	2 to 8°C	4 to 8°C non-punctured vials
Open Vial Claim	N/A, single-use, disposable, useimmediately	May be kept at room temperature for amaximum of one hour.
Procedural Steps	1) Squeeze dropper to break glassampoule inside2) Mix thoroughly by repeated inversion3) Dispense first drop into cap4) Dispense second drop onto the sampleport of the cuvette	1) Dispense diluent into control vial viasyringe and swirl to rehydrate2) Stabilize at room temperature for 15minutes then swirl to dissolve3) Add calcium chloride via syringe andagitate end to end4) Draw sample into syringe anddispense onto the sample port of thecuvette
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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:

× 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

Regulation Number and Section

§ 864.5425 Multipurpose system for in vitro coagulation studies.

(a)
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.(b)
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.

Acceptance Criteria and Device Performance

Additional Information:

Footnotes

SECTION 5: 510(k) Summary

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

[B] 807.92 (a)(2): Device name - Trade Name and Common Name, and Classification

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

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

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

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

Conclusion

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

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

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Maria M. Chan -S

Indications for Use

Maria M. Chan -S

§ 864.5425 Multipurpose system for in vitro coagulation studies.