HemosIL Liquid Heparin: Automated chromogenic assay for the quantitative determination of . unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
HemosIL Heparin Calibrators: For the calibration of the HemosIL Liquid Heparin assay on IL . Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
HemosIL LMW Heparin Controls (Assayed): For the quality control of the HemosIL Liquid . Heparin assay when testing for low molecular weight heparin (LMW) on IL Coagulation Systems (ACL TOP® Family, ACL" ELITE/ ELITE PRO®8/9/10000 and ACL Futura/ACL Advance Systems).
· HemosIL UF Heparin Controls (Assayed): For the quality control of the HemosIL Liquid Heparin assay when testing for unfractionated heparin (UFH) on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
For in vitro diagnostic use.

Device Description

HemosIL Liquid Heparin .
One stage chromogenic assay based on a synthetic chromogenic substrate and on Factor Xa inactivation. Heparin levels in patient plasma are measured automatically on IL Coagulation Systems.
Heparin is analyzed as a complex with antithrombin present in the sample. The concentration of this complex is dependent on the availability of the patient's endogenous antithrombin. When the Heparin - antithrombin complex is formed, two competing reactions take place.

1. Factor Xa is neutralized by heparin-antithrombin complex.
1. Residual Factor Xa is quantified with a synthetic chromogenic substrate. The paranitroaniline released is monitored kinetically at 405 nm and is inversely proportional to the heparin level in the sample.
HemosIL Heparin Calibrators .
Lyophilized calibrators prepared from human citrated plasma by means of a dedicated process at three different heparin concentrations: 0, 0.8 and 2.0 IU/mL and are traceable to the WHO International Standards for LMW and UF Heparin.
HemosIL LMW Heparin Controls (Assayed) .
Lyophilized controls prepared from human citrated plasma by means of a dedicated process at two different LMW heparin concentrations (low and high) for the assessment of precision and accuracy of the Liquid Heparin assay when testing for low molecular weight heparin.
HemosIL UF Heparin Controls (Assayed) .
Lyophilized controls prepared from human citrated plasma by means of a dedicated process at two different UF heparin concentrations (low and high) for the assessment of precision and accuracy of the Liquid Heparin assay when testing for unfractionated heparin.

AI/ML Overview

HemosIL Liquid Heparin Assay, Controls, and Calibrators - Acceptance Criteria & Study Summary

This document describes the acceptance criteria and supporting studies for the HemosIL Liquid Heparin Assay, HemosIL Heparin Calibrators, HemosIL LMW Heparin Controls, and HemosIL UF Heparin Controls, as extracted from the provided 510(k) summary (K090209).

1. Acceptance Criteria and Reported Device Performance

The 510(k) submission primarily demonstrates substantial equivalence through method comparison studies and precision assessments. The acceptance criteria for substantial equivalence are implicitly defined by comparing the new device's performance to that of predicate devices and demonstrating acceptable precision.

The following table summarizes the reported device performance, particularly focusing on precision and method comparison results, which serve as the evidence for meeting implied acceptance criteria for assay performance characteristics relevant to quantitative diagnostic devices. Specific, explicit acceptance criteria (e.g., "CV % must be < X%") are not directly stated in the provided text but are inferred from the presentation of the precision data and the successful substantial equivalence determination by the FDA. The method comparison data implies acceptance if the slope and correlation coefficient (r) are sufficiently close to 1, demonstrating agreement with the predicate.

Table 1: Acceptance Criteria (Implied) and Reported Device Performance

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Precision	CV % (Within run) and CV % (Total) for UFH and LMWH controls should be within acceptable limits for a clinical diagnostic assay.	ACL 8/9/1000/ELITE/ELITE PRO: - UFH Low: Mean 0.39 IU/mL, C.V.% (Within run) 4.0%, C.V.% (Total) 6.7% - UFH High: Mean 0.69 IU/mL, C.V.% (Within run) 1.0%, C.V.% (Total) 3.7% - LMWH Low: Mean 0.49 IU/mL, C.V.% (Within run) 5.5%, C.V.% (Total) 5.7% - LMWH High: Mean 1.31 IU/mL, C.V.% (Within run) 3.3%, C.V.% (Total) 4.0% ACL Futura/ACL Advance: - UFH Low: Mean 0.41 IU/mL, C.V.% (Within run) 4.4%, C.V.% (Total) 4.4% - UFH High: Mean 0.69 IU/mL, C.V.% (Within run) 1.3%, C.V.% (Total) 1.7% - LMWH Low: Mean 0.56 IU/mL, C.V.% (Within run) 2.5%, C.V.% (Total) 3.5% - LMWH High: Mean 1.37 IU/mL, C.V.% (Within run) 1.1%, C.V.% (Total) 1.6% ACL TOP Family: - UFH Low: Mean 0.41 IU/mL, C.V.% (Within run) 2.4%, C.V.% (Total) 3.3% - UFH High: Mean 0.68 IU/mL, C.V.% (Within run) 1.0%, C.V.% (Total) 1.6% - LMWH Low: Mean 0.55 IU/mL, C.V.% (Within run) 3.5%, C.V.% (Total) 4.5% - LMWH High: Mean 1.35 IU/mL, C.V.% (Within run) 1.9%, C.V.% (Total) 2.5%
Method Comparison (Slope)	Slope should be close to 1.0, indicating good agreement with the predicate device.	In-house Study: - ACL ELITE: 0.894 - ACL Advance: 1.067 - ACL TOP: 0.946 Field Sites Study: - ACL ELITE: 1.032 - ACL Advance: 1.007 - ACL TOP: 0.952
Method Comparison (r)	Correlation coefficient (r) should be close to 1.0, indicating a strong linear relationship with the predicate device.	In-house Study: - ACL ELITE: 0.907 - ACL Advance: 0.946 - ACL TOP: 0.958 Field Sites Study: - ACL ELITE: 0.949 - ACL Advance: 0.957 - ACL TOP: 0.978
Linearity	Device should be linear up to 2.0 IU/mL for UFH and LMWH activity across all specified IL Coagulation Systems.	Reported linearity for the new device is Up to 2.0 IU/mL for ACL 8/9/1000/ELITE/ELITE PRO, ACL Futura/ACL Advance, and ACL TOP Family. This is an improvement over the predicate device, which had linearity up to 1.0 IU/mL or 1.1 IU/mL depending on the system.

2. Sample Sizes and Data Provenance for the Test Set

The studies conducted for performance assessment include precision and method comparison.

Precision: "Precision was assessed over multiple runs using the two levels of both UFH and LMWH Controls on representative IL Coagulation Systems." The exact number of samples (individual test results) for precision is not explicitly stated, but it involved multiple runs of two levels of controls for both UFH and LMWH.
Method Comparison - In-house:
- Sample sizes (n):
  - ACL ELITE: 124 samples
  - ACL Advance: 152 samples
  - ACL TOP: 148 samples
- Data Provenance: "samples from patients undergoing heparin therapy." The country of origin is not specified, but the "in-house" designation suggests it was likely from a single internal site, possibly in the USA (where the applicant is located). The data is retrospective in the sense that these are patient samples, but the comparison itself is a prospective analysis of these samples using both devices.
Method Comparison - Field Sites:
- Sample sizes (n):
  - ACL ELITE: 114 samples
  - ACL Advance: 111 samples
  - ACL TOP: 81 samples
- Data Provenance: "samples from patients undergoing heparin therapy." Three field site studies were performed. The country of origin is not specified, but multi-site studies often involve diverse populations. The data is retrospective in the sense that these are patient samples, but the comparison itself is a prospective analysis of these samples using both devices.

3. Number of Experts and Qualifications for Ground Truth

The provided summary does not explicitly mention the use of experts to establish a "ground truth" in the typical sense (e.g., radiological reads). For this type of in vitro diagnostic device (quantitative assay for heparin activity), the "ground truth" for the method comparison studies is typically established by the predicate device's results. The predicate device (HemosIL Heparin) is considered the reference standard against which the new device's performance is compared. Therefore, no external experts were used in this manner.

4. Adjudication Method for the Test Set

Since the ground truth for this type of quantitative assay is established by the reading of the predicate device, there is no mention of an adjudication method involving multiple human readers as described (e.g., 2+1, 3+1). The comparison is directly between the numerical outputs of the new device and the predicate device.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. This type of study is more common for imaging or interpretive diagnostic devices where human readers provide interpretations. For quantitative assays like the HemosIL Liquid Heparin, the focus is on the agreement between the new test results and a reference method/device, and the precision of the new test, rather than human reader improvement with AI assistance.

6. Standalone Performance Study (Algorithm Only)

The entire study focuses on the standalone performance of the HemosIL Liquid Heparin assay (an algorithm-driven instrument-based test) compared to its predicate and its internal precision. There is no human-in-the-loop performance described, as it is an automated chromogenic assay run on IL Coagulation Systems. Therefore, yes, a standalone (algorithm only) performance study was conducted.

7. Type of Ground Truth Used

The ground truth for the method comparison studies was established by the predicate device (HemosIL Heparin). For precision studies, the ground truth for the controls is their assigned nominal values, and the study assesses the reproducibility of the new device's measurements around these values.

8. Sample Size for the Training Set

The provided 510(k) summary does not mention a "training set" in the context of machine learning or AI development. This device is an automated chromogenic assay; its performance is based on chemical reactions and optical detection, not a machine learning model that requires training data in the typical sense. Data used for initial development or optimization of the assay formulation would not be referred to as a "training set" in this context.

9. How Ground Truth for the Training Set Was Established

As there is no "training set" in the context of an AI/ML algorithm for this device, this question is not applicable. The assay's development would involve standard analytical chemistry and immunoassay development pipelines, with "ground truth" being established through reference materials, spiking studies, and established analytical methods.

Summary

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510(k) Summary

Κοροζος

Applicant Contact Information:

JUN - 2 2009

Applicant:	Instrumentation Laboratory Co.
Address:	113 Hartwell AvenueLexington, MA 02421
Contact Person:	Carol Marble, Regulatory Affairs Director
Phone Number:	781-861-4467
Fax Number:	781-861-4207

April 23, 2009 Revision Date:

Device Trade Names (Products Sold Separately):

HemosIL Liquid Heparin HemosIL Heparin Calibrators HemosIL LMW Heparin Controls HemosIL UF Heparin Controls

Device Regulatory Information:

Heparin Assay:	Class II	Product Code: KFF	21 CFR 864.7525
Calibrators:	Class II	Product Code: JIS	21 CFR 862.1150
Controls:	Class II	Product Code: GGN	21 CFR 864.5425

Predicate Devices:

K980242	HemosIL Heparin
K030964	Calibration Plasma LMW Heparin
K030965	Control Plasma LMW Heparin

Device Intended Uses:

HemosIL Liquid Heparin: Automated chromogenic assay for the quantitative determination of . unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
HemosIL Heparin Calibrators: For the calibration of the HemosIL Liquid Heparin assay on IL . Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
HemosIL LMW Heparin Controls (Assayed): For the quality control of the HemosIL Liquid . Heparin assay when testing for low molecular weight heparin (LMW) on IL Coagulation Systems (ACL TOP® Family, ACL" ELITE/ ELITE PRO®8/9/10000 and ACL Futura/ACL Advance Systems).
· HemosIL UF Heparin Controls (Assayed): For the quality control of the HemosIL Liquid Heparin assay when testing for unfractionated heparin (UFH) on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).

K090209 - HemosIL Liquid Heparin Assay, Controls and Calibrators Attachment G

Page 1 of 4

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Device Descriptions:

HemosIL Liquid Heparin .
One stage chromogenic assay based on a synthetic chromogenic substrate and on Factor Xa inactivation. Heparin levels in patient plasma are measured automatically on IL Coagulation Systems.

Heparin is analyzed as a complex with antithrombin present in the sample. The concentration of this complex is dependent on the availability of the patient's endogenous antithrombin. When the Heparin - antithrombin complex is formed, two competing reactions take place.

1. Factor Xa is neutralized by heparin-antithrombin complex.
1. Residual Factor Xa is quantified with a synthetic chromogenic substrate. The paranitroaniline released is monitored kinetically at 405 nm and is inversely proportional to the heparin level in the sample.
HemosIL Heparin Calibrators .

Lyophilized calibrators prepared from human citrated plasma by means of a dedicated process at three different heparin concentrations: 0, 0.8 and 2.0 IU/mL and are traceable to the WHO International Standards for LMW and UF Heparin.

HemosIL LMW Heparin Controls (Assayed) .
Lyophilized controls prepared from human citrated plasma by means of a dedicated process at two different LMW heparin concentrations (low and high) for the assessment of precision and accuracy of the Liquid Heparin assay when testing for low molecular weight heparin.
HemosIL UF Heparin Controls (Assayed) .
Lyophilized controls prepared from human citrated plasma by means of a dedicated process at two different UF heparin concentrations (low and high) for the assessment of precision and accuracy of the Liquid Heparin assay when testing for unfractionated heparin.

Statement of Technological Characteristics of the Device Compared to Predicate Devices:

HemosIL Liquid Heparin is substantially equivalent to HemosIL Heparin (K980242) in . performance and intended use.
HemosIL Heparin Calibrators are substantially equivalent to Calibration Plasma LMW . Heparin (K030964) in performance and intended use, except that the new calibrators are intended for use with both low molecular weight and unfractionated heparin testing.
HemosIL LMW Heparin Controls and HemosIL UF Heparin Controls are substantially . equivalent to Control Plasma LMW Heparin (K030965) in performance and intended use, except that HemosIL UF Heparin Controls are intended specifically for use with unfractionated heparin testing.

K090209 - HemosIL Liquid Heparin Assay, Controls and Calibrators -Page 2 of 4 Attachment G

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510(k) Summary (Cont.)

Substantial Equivalence Comparison Table:

Characteristic	New Device:HemosIL Liquid Heparin	Predicate Device:HemosIL Heparin (K980242)	ACL 8/9/1000/ELITE/ELITE PRO	Mean (IU/mL)	CV % (Within run)	CV % (Total)
Intended Use	Automated chromogenic assay for thequantitative determination of unfractionatedheparin (UFH) and low molecular weightheparin (LMWH) activity in human citratedplasma on IL Coagulation Systems (ACLTOP® Family, ACL™ ELITE/ELITEPRO®/8/9/10000 and ACL Futura/ACLAdvance Systems).	Same	UFH Low	0.39	4.0	6.7
Form	Liquid Substrate and FXa Reagent	Lyophilized Substrate and FXa Reagent	UFH High	0.69	1.0	3.7
Test Principle	Chromogenic Assay	Same	LMWH Low	0.49	5.5	5.7
Sample Type	Citrated Plasma	Same	LMWH High	1.31	3.3	4.0
Expected Values	To obtain an optimal effect with minimumrisk of bleeding or thromboemboliccomplications the heparin activity should bein the range recommended by the heparinmanufacturer.	Same	ACL Futura/ACL Advance	Mean (IU/mL)	CV % (Within run)	CV % (Total)
Linearity	ACL 8/9/1000/ELITE/ELITE PRO Up to 2.0 IU/mLACL Futura/ACL Advance Up to 2.0 IU/mLACL TOP Family Up to 2.0 IU/mL	ACL 8/9/1000/ELITE/ELITE PRO Up to 1.0 IU/mLACL Futura/ACL Advance Up to 1.0 IU/mLACL TOP Family Up to 1.1 IU/mL	UFH Low	0.41	4.4	4.4
Characteristic	New Device:HemosIL Heparin Calibrators	Predicate Device:Calibration Plasma LMW Heparin(K030964)	UFH High	0.69	1.3	1.7
Intended Use	For the calibration of the HemosIL LiquidHeparin assay on IL Coagulation Systems(ACL TOP® Family, ACL™ ELITE/ELITEPRO®/8/9/10000 and ACL Futura/ACLAdvance Systems).	For preparation of calibration curves foruse in chromogenic heparin assays.	LMWH Low	0.56	2.5	3.5
Form	Lyophilized	Same	LMWH High	1.37	1.1	1.6
Characteristic	New Devices (Sold Separately):HemosIL LMW Heparin ControlsHemosIL UF Heparin Controls	Predicate Device:Control Plasma LMW Heparin(K030965)	ACL TOP Family	Mean (IU/mL)	CV % (Within run)	CV % (Total)
Intended Use	LMWH Controls: For the quality control ofthe HemosIL Liquid Heparin assay whentesting for low molecular weight heparin(LMW) on IL Coagulation Systems (ACLTOP® Family, ACL™ ELITE/ELITEPRO®/8/9/10000 and ACL Futura/ACLAdvance Systems).UFH Controls: For the quality control of theHemosIL Liquid Heparin assay whentesting for unfractionated heparin (UFH) onIL Coagulation Systems.	For the quality control of chromogenicheparin assays.	UFH Low	0.41	2.4	3.3
UFH High	0.68	1.0	1.6
LMWH Low	0.55	3.5	4.5
LMWH High	1.35	1.9	2.5

K090209 -- HemosIL Liquid Heparin Assay, Controls and Calibrators Attachment G

…

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510(k) Summary (Cont.)

Summary Performance Data:

. . . .

Precision

Precision was assessed over multiple runs using the two levels of both UFH and LMWH Controls on representative IL Coagulation Systems:

Method Comparison - In-house

An in-house method comparison study was performed, using samples from patients undergoing heparin therapy, to compare the performance of HemosIL Liquid Heparin versus the predicate device (HemosIL Heparin) on representative IL instrument platforms with the following results:

IL System	n	Slope	r
ACL ELITE	124	0.894	0.907
ACL Advance	152	1.067	0.946
ACL TOP	148	0.946	0.958

Method Comparison - Field Sites

Three field site studies were performed, using samples from patients undergoing heparin therapy, Thee note the performance of HemosIL Liquid Heparin versus the predicate device (HemosIL Heparin) on representative IL instrument platforms with the following results:

IL System	n	Slope	r
ACL ELITE	114	1.032	0.949
ACL Advance	111	1.007	0.957
ACL TOP	81	0.952	0.978

Attachment G

K090209 -- HemosIL Liquid Heparin Assay, Controls and Calibrators

Page 4 of 4

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Instrumentation Laboratory Co. c/o Ms. Carol Marble Regulatory Affairs Director 113 Hartwell Avenue Lexington, MA 02421

JUN - 2 2009

Re: K090209

Trade/Device Name: HemosIL Liquid Heparin, HemosIL Heparin Calibrators, HemosIL LMW Heparin Controls and HemosIL UF Heparin Controls

Regulation Number: 21 CFR §864.7525 Regulation Name: Heparin Assay Regulatory Class: Class II Product Code: KFF, JIS, GGN Dated: April 23, 2009 Received: April 24, 2009

Dear Ms. Marble:

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 either class II (Special Controls) or class III (PMA), 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

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Page 2 - Ms. Carol Marble

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) 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 Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

m. Clan

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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Indications for Use Statement

Ko90209 510(k) Number (if known):

Device Name:

HemosIL Liquid Heparin HemosIL Heparin Calibrators HemosIL LMW Heparin Controls HemosIL UF Heparin Controls

Indications for Use:

HemosIL Liquid Heparin: Automated chromogenic assay for the quantitative determination . of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
HemosIL Heparin Calibrators: For the calibration of the HemosIL Liquid Heparin assay on t IL Coagulation Systems (ACL TOP® Family, ACL" ELITE/ELITE PRO® 8/9/10000 and ACL Futura/ACL Advance Systems).
HemosIL LMW Heparin Controls (Assayed): For the quality control of the HemosIL Liguid Heparin assay when testing for low molecular weight heparin (LMW) on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
HemosIL UF Heparin Controls (Assayed): For the quality control of the HemosIL Liguid Heparin assay when testing for unfractionated heparin (UFH) on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).

For in vitro diagnostic use.

ﮯ Prescription Use (Part 21 CFR 801 Subpart D)

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 Diagnostic Devices (OIVD)

ie M. Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K090209

Section 4

HemosIL Liquid Heparin Kit, Calibrators and Controls 510(k)

Page 1 of 1

Regulation Number and Section

§ 864.7525 Heparin assay.

(a)
Identification. A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).(b)
Classification. Class II (performance standards).