(65 days)
Not Found
No
The device is a quality control material for laboratory assays and does not involve any computational analysis or algorithms.
No
This device is a quality control intended for in-vitro diagnostic use in Lupus Anticoagulant assays, not for direct therapeutic intervention on a patient.
No
Explanation: The device is described as a "Quality Control" for "Lupus Anticoagulant assays" and is explicitly stated "For in-vitro diagnostic use only." It is used to ensure the accuracy of diagnostic tests, not to perform a diagnosis itself.
No
The device description clearly states it is a "lyophilized preparation" and consists of "vials of lyophilized controls," indicating a physical, non-software component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the controls are "intended for use as an LA Positive Quality Control" and "intended for use as an LA Negative Quality Control of Lupus Anticoagulant assays". This indicates they are used to evaluate the performance of diagnostic tests.
- Device Description: The description details the composition of the controls, which are preparations used in laboratory testing.
- Intended User / Care Setting: It clearly states "For in-vitro diagnostic use only." and "For prescription use." This directly identifies the device's purpose and regulatory classification.
- Performance Studies: While many sections are marked "Not Applicable" for this specific submission, the inclusion of sections like "Analytical performance" and "Clinical Studies" (even if not applicable to the control itself) is typical for IVD submissions.
- Predicate Device(s): The mention of a predicate device (K110031) which is also named "HemosIL LA Negative Control & HemosIL LA Positive Control" further confirms that these are IVD controls.
Based on the provided information, the device is clearly intended for use in a laboratory setting to assess the performance of diagnostic tests for Lupus Anticoagulant, which falls under the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HemosIL LA Positive Control is intended for use as an LA Positive Quality Control of Lupus Anticoagulant assays (HemosIL dRVVT Screen/dRVVT Confirm, HemosIL LAC Screen/LAC Confirm and HemosIL Silica Clotting Time Screen and Confirm) on IL Coagulation systems [ACL TOP] Family; ACL ELITE /ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].
HemosIL LA Negative Control is intended for use as an LA Negative Quality Control of Lupus Anticoagulant assays (HemosIL dRVVT Screen/dRVVT Confirm, HemosIL LAC Screen/LAC Confirm and HemosIL Silica Clotting Time Screen and Confirm) on IL Coagulation systems [ACL TOP Family; ACL ELITE /ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].
Product codes
GGN, GGC, GIZ
Device Description
Hemost LA Negative Control is a lyophilized preparation using human citrated platelet-poor plasma to make a pooled normal plasma with added buffer. The device consists of ten 1-ml vials of lyophilized controls per package.
Hemost LA Positive Control is a lyophilized preparation from human donors exhibiting the presence of anti-phospholipid antibodies with added buffer. The device consists of ten 1-ml vials of lyophilized controls per package.
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
For in-vitro diagnostic use only. For prescription use.
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)
Analytical performance
- Precision/Reproducibility: As established in K110031. a.
- Linearity/assay reportable range: Not Applicable b.
- C. Traceability, Stability, Expected values (controls, calibrators, or methods): Lyophilized shelf life at 2-8°C: 2 years
After Reconstitution: 24 hours at 2-8℃ in its closed original vial. Reconstituted Frozen Stability: 3 weeks at -20°C in its closed original vial.
On Board Stability:
- 24 hours at 15°C on-board the ACL TOP Family in the original vial,
- 4 hours on the ACL ELITE/ELITE PRO/8/9/10000,
- ← 4 hours on the ACL Futura/ACL Advance or
- 4 hours on the ACL Classic (100-7000) Systems.
- d. Detection limit: NA
- e. Analytical specificity: Not Applicable
- f. Assay cut-off: Not Applicable
-
- Comparison studies:
- Method comparison with predicate device: Not Applicable 0.
- b. Matrix Comparison: Not Applicable
- Clinical Studies: 3.
- a. Clinical Sensitivity: Not Applicable
- b. Clinical Specificity: Not Applicable
- C. Other clinical supportive data (when a. and b. are not applicable): NA
- Clinical cut-off: Not Applicable 4.
- Expected values/Reference range: Established in K110031 5.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Applicable
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
JAN - 4 2012
510K SUMMARY
ASSAY ONLY TEMPLATE
- A. 510(k) Number TBD B. Purpose for Addition of reconstituted frozen stability claims Submission C. Measurand Controls for Lupus Anticoagulant (LA) Assayed Controls D. Type of Test Applicant E. Instrumentation Laboratory Co. F. Proprietary & HemosIL LA Positive Control & HemosIL LA Negative Control Established Names
G. Regulatory Information
-
- Regulation section: 21CFR §864.5425, Multipurpose system for in vitro
- coagulation studies.
-
- Classification: Class II
-
- Product code: GGN (Plasma Coagulation Control)
-
- Panel: 81 Hematology
ાં. Intended Use
-
- Intended use(s):
HemosIL LA Negative Control
For use as an LA Negative Quality Control of Lupus Anticoagulant assays (HemoslL dRVVT Screen/dRVVT Confirm, LAC Screen/LAC Confirm; HemosIL Silica Clotting Time) on IL Coagulation systems [ACL TOP Family; ACL ELITE /ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].
HemosIL LA Positive Control
For use as an LA Positive Quality Control of Lupus Anticoagulant assays (Hemos IL dRVVT Screen/dRVVT Confirm, LAC Screen/LAC Confirm; HemosIL Silica Clotting Time) on IL Coagulation systems [ACL TOP Family; ACL ELITE /ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].
-
- Indication(s) for use: Same as above
-
- Special conditions for use statement(s): For in-vitro diagnostic use only. For prescription use.
-
- Special instrument requirements: IL Coagulation systems {ACL TOP Family; ACL ELITE /ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].
1
Device Description
Hemost LA Negative Control is a lyophilized preparation using human citrated platelet-poor plasma to make a pooled normal plasma with added buffer. The device consists of ten 1-ml vials of lyophilized controls per package.
Hemost LA Positive Control is a lyophilized preparation from human donors exhibiting the presence of anti-phospholipid antibodies with added buffer. The device consists of ten 1-ml vials of lyophilized controls per package.
J. Substantial Equivalence Information
-
- Predicate device name(s): HemosIL LA Negative Control & HemosIL LA Positive Control (self)
-
- Predicate 510(k) number(s): KI10033
-
- Comparison with predicate:
Hemosil LA Negative Control
The HemosIL LA Negative Control applicant is Substantially Equivalent to its predicate, the HemosIL LA Negative Control that was cleared under K110031, in intended use, fundamental scientific technology, and product composition. The products are identical in performance in all aspects, except for their reconstituted stability claims. The applicant has a reconstituted stability of 3 weeks at -20°C in its closed original vial.
HemosIL LA Positive Control
The HemosIL LA Positive Control applicant is Substantially Equivalent to its predicate, the HemosIL LA Positive Control that was cleared under K110031, in intended use, fundamental scientific technology, and product composition. The products are identical in performance in all aspects, except for their reconstituted stability claims. The applicant has a reconstituted stability of 3 weeks at -20°C in its closed original vial.
- K.
L.
Standard/Guidance Document Referenced (if applicable)
Guidance for Industry and FDA Staff - Assayed and Unassayed Quality Control Material (UCM79179), June 7, 2007.
Test Principle
LA Positive control is a lyophilized preparation from human donors with antiphospholipid antibodies with added buffer. LA Negative control consists of a pool of normal human citrated platelet-poor plasma.
The controls are used to assess the precision and accuracy of Lupus Anticoagulant (LA) assays performed on IL Coagulation instrument platforms using HemosIL LA Reagents.
Performance Characteristics M.
Analytical performance
- Precision/Reproducibility: As established in K110031. a.
- Linearity/assay reportable range: Not Applicable b.
2
- C. Traceability, Stability, Expected values (controls, calibrators, or methods): Lyophilized shelf life at 2-8°C: 2 years
After Reconstitution: 24 hours at 2-8℃ in its closed original vial. Reconstituted Frozen Stability: 3 weeks at -20°C in its closed original vial.
On Board Stability:
- 24 hours at 15°C on-board the ACL TOP Family in the original vial,
- 4 hours on the ACL ELITE/ELITE PRO/8/9/10000,
- ← 4 hours on the ACL Futura/ACL Advance or
- 4 hours on the ACL Classic (100-7000) Systems.
- d. Detection limit: NA
- e. Analytical specificity: Not Applicable
- f. Assay cut-off: Not Applicable
-
- Comparison studies:
- Method comparison with predicate device: Not Applicable 0.
- b. Matrix Comparison: Not Applicable
- Clinical Studies: 3.
- a. Clinical Sensitivity: Not Applicable
- b. Clinical Specificity: Not Applicable
- C. Other clinical supportive data (when a. and b. are not applicable): NA
- Clinical cut-off: Not Applicable 4.
- Expected values/Reference range: Established in K110031 5.
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. |
|---|---|
| Contact: | Jacqueline Emery, BSEE, Regulatory Affairs Manager |
| Mailing address: | 180 Hartwell Road, Bedford, MA 01730, USA |
| Phone #: | 781-861-4350 |
| Fax #: | 781-861-4207 |
| E-mail address: | jemery@ilww.com |
| Date Prepared: | October 27th, 2011 |
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a staff entwined by two snakes and topped with wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Instrumentation Laboratory Co. c/o Jacqueline Emery Regulatory Affairs Manager 180 Hartwell Road Bedford, MA 01730
JAN n 4 2012
Re: K113211
HemosIL LA Positive Control & HemosIL LA Negative Control Regulation Number: 21 CFR § 864.5425 Regulation Name: Multipurpose system for in vitro coagulation studies Regulatory Class: Class II Product Code: GGN, GGC, GIZ Dated: October 27, 2011 Received: October 31, 2011
Dear Ms. Emery:
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.
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, Code of Federal Regulations (CFR), Parts 800 to 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 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 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
4
Page 2 - Ms. Jacqueline Emery
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 notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note 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 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/cdrh/industry/support/index.html.
Sincerely yours,
Reena Philip
09 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
5
SPECIAL 510K SUBMISSSION
Indications for Use Statement
510(k) Number (if known): K113211
HemosIL® LA Positive Control & HemosIL® LA Negative Control Device Name:
Indications for Use:
HemosIL LA Positive Control is intended for use as an LA Positive Quality Control of Lupus Anticoagulant assays (HemosIL dRVVT Screen/dRVVT Confirm, HemosIL LAC Screen/LAC Confirm and HemosIL Silica Clotting Time Screen and Confirm) on IL Coagulation systems [ACL TOP] Family; ACL ELITE /ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].
HemosIL LA Negative Control is intended for use as an LA Negative Quality Control of Lupus Anticoagulant assays (HemosIL dRVVT Screen/dRVVT Confirm, HemosIL LAC Screen/LAC Confirm and HemosIL Silica Clotting Time Screen and Confirm) on IL Coagulation systems [ACL TOP Family; ACL ELITE /ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].
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)
Leach R. Kirk
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K113211