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)].

Device Description

HemosIL 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.

HemosIL 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the HemosIL LA Positive Control & HemosIL LA Negative Control, primarily focusing on establishing a new reconstituted frozen stability claim. The submission aims to demonstrate substantial equivalence to a previously cleared device (K110031) with this added claim.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated Goal)	Reported Device Performance
Reconstituted Frozen Stability: 3 weeks at -20°C in its closed original vial.	The applicant has a reconstituted stability of 3 weeks at -20°C in its closed original vial.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a sample size for a test set used to prove the new stability claim. It also does not specify the provenance of any data used for this specific stability study (e.g., country of origin, retrospective or prospective).

The submission focuses on a new stability claim for existing controls, implying that tests would have been performed to validate this. However, the details of these tests (such as the number of control vials tested, the number of measurements taken, or the specific experimental design) are not provided in this summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document. For a quality control product like this, "ground truth" typically refers to the confirmed stability characteristics and performance of the control. The establishment of such ground truth would typically be done through controlled laboratory studies and adherence to established quality control guidelines, rather than by expert consensus in the way clinical diagnostic devices might.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of a quality control product and the type of performance characteristic being evaluated (stability), an adjudication method in the context of expert review or consensus, such as 2+1 or 3+1, is unlikely to be relevant or applicable. Performance would be assessed against predefined analytical specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This information is not applicable and not provided. The device is a quality control material for in vitro coagulation studies, not an AI-assisted diagnostic tool or an imaging device that involves human reader interpretation. Therefore, an MRMC study or a comparison of human reader performance with and without AI assistance is not relevant to this device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable and not provided. The device is a laboratory control, not an algorithm. Its performance is evaluated analytically, not as a standalone algorithm.

7. The Type of Ground Truth Used

For the specific new claim being made (reconstituted frozen stability), the "ground truth" would be established through analytical testing and measurements of the control's performance over the specified stability period (3 weeks at -20°C). This would involve measuring the control's activity or characteristics using the target LA assays and instruments, and demonstrating that these measurements remain within pre-defined acceptable ranges throughout the claimed stability period. The document refers to "Performance Characteristics M. Analytical performance" and "c. Traceability, Stability, Expected values (controls, calibrators, or methods)" as sections where these details would typically be found, stating "Reconstituted Frozen Stability: 3 weeks at -20°C in its closed original vial."

8. The Sample Size for the Training Set

This information is not provided. As a quality control product, the concept of a "training set" in the context of machine learning algorithms is not applicable here. The development and manufacturing of the control would involve process validation and extensive quality control testing, but not a machine learning training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided for the reasons stated in point 8.

Summary

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K113211

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

1. Regulation section: 21CFR §864.5425, Multipurpose system for in vitro
- coagulation studies.
1. Classification: Class II
1. Product code: GGN (Plasma Coagulation Control)
1. Panel: 81 Hematology

ાં. Intended Use

1. 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)].

1. Indication(s) for use: Same as above
1. Special conditions for use statement(s): For in-vitro diagnostic use only. For prescription use.
1. Special instrument requirements: IL Coagulation systems {ACL TOP Family; ACL ELITE /ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)].

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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

1. Predicate device name(s): HemosIL LA Negative Control & HemosIL LA Positive Control (self)
1. Predicate 510(k) number(s): KI10033
1. 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.

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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
1. 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

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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

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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 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

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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:

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

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.