(457 days)
Not Found
No
The device is a quality control material for coagulation tests and does not describe any computational or analytical functions that would involve AI/ML.
No
The device is described as quality control material for coagulation tests, not a device used for treating patients.
No
The device is described as a control for quality assurance of diagnostic tests, not a diagnostic device itself.
No
The device description clearly states it is a "lyophilized whole blood preparation" and a "material" that is "lyophilized in glass ampoules," indicating it is a physical substance and not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the controls are for the "quality control of quantitative coagulation test" on specific instruments (HEMOCHRON® Jr. Signature+ and HEMOCHRON® Signature Elite). Quality control materials used to verify the performance of diagnostic tests are considered IVDs.
- Device Description: The description details a "lyophilized whole blood preparation" that is rehydrated to form a "liquid whole blood control." This material is used in vitro (outside the body) to assess the accuracy and precision of the coagulation tests.
- Performance Studies: The document includes performance studies related to precision and stability, which are typical evaluations for IVD devices.
- Predicate Devices: The predicate devices listed are also described as including "whole blood controls," further indicating that these types of materials are classified as IVDs.
Therefore, based on the provided information, the directCHECK® Whole Blood Controls fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
GGN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
§ 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.
0
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
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.
1
[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 | |
| Controls for HEMOCHRON® ACT- | ||
| LR Assay | ||
| K120977 | HEMOCHRON® Jr. | |
| Microcoagulation Low Range ACT, | ||
| JQC-ACT-LR | ||
| K960749 | ||
| 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 HEMOCHRON® Jr. | |
| Microcoagulation Whole Blood | ||
| Controls are lyophilized whole blood | ||
| preparations which have been assayed | ||
| and are intended to be used to perform | ||
| quality control assays using the | ||
| HEMOCHRON® Jr. Microcoagulation | ||
| ACT-LR test cuvettes. | ||
| Material Composition | Non-human plasma, non-human red blood | |
| cells and diluent (containing calcium | ||
| chloride). | Non-human plasma, non-human red | |
| blood cells, diluent and calcium | ||
| chloride. | ||
| Form | Ready to use squeezable dropper | |
| containing liquid diluent and glass | ||
| ampoule which contains lyophilized | ||
| pellet. | 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, use | |
| immediately. | May be kept at room temperature for a | |
| maximum of one hour. | ||
| Procedural Steps | 1) Squeeze dropper to break glass | |
| ampoule inside |
- Mix thoroughly by repeated inversion
- Dispense first drop into cap
- Dispense second drop onto the sample
port of the cuvette | 1) Dispense diluent into control vial via
syringe and swirl to rehydrate - Stabilize at room temperature for 15
minutes then swirl to dissolve - Add calcium chloride via syringe and
agitate end to end - Draw sample into syringe and
dispense onto the sample port of the
cuvette |
| Analyte | ACT-LR | ACT-LR |
| CHARACTERISTIC | MODIFIED DEVICE:
directCHECK® Whole Blood
Controls for HEMOCHRON® ACT+
Assay
K1210977 | PREDICATE DEVICE:
HEMOCHRON®
Microcoagulation Activated Clotting
Time PLUS (ACT+) test, QC-ACT+
K941007 |
| Intended 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 ACT+ Quality Control Product is a
lyophilized whole blood preparation
that is used to perform a quality control
assay using the HEMOCHRON® Jr.
Microcoagulation' ACT+ test cuvette. |
| Material Composition | Non-human plasma, non-human red blood
cells and diluent (containing calcium
chloride). | Non-human plasma, non-human red
blood cells, diluent and calcium
chloride. |
| Form | Ready to use squeezable dropper
containing liquid diluent and glass
ampoule which contains lyophilized
pellet. | 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, use
immediately | May be kept at room temperature for a
maximum of one hour. |
| Procedural Steps | 1) Squeeze dropper to break glass
ampoule inside - Mix thoroughly by repeated inversion
- Dispense first drop into cap
- Dispense second drop onto the sample
port of the cuvette | 1) Dispense diluent into control vial via
syringe and swirl to rehydrate - Stabilize at room temperature for 15
minutes then swirl to dissolve - Add calcium chloride via syringe and
agitate end to end - Draw sample into syringe and
dispense onto the sample port of the
cuvette |
| Analyte | ACT+ | ACT+ |
2
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.
3
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