The STA® - Liquid Anti-Xa kits are intended for use with STA-R®, STA Compact® and STA Satellite® analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.

The STA® - Multi Hep Calibrator is a set of calibrator plasmas intended for use with STA-R®, STA Compact®, and STA Satellite® analyzers, for the calibration of heparin (UFH and LMWH) activity assay by measuring the anti-Xa activity.

The STA® - Quality HNF/UFH kit is a set of two plasmas intended for the quality control of unfractionated heparin (UFH) activity assay by measuring the anti-Xa activity performed on STA-R®, STA Compact®, and STA Satellite® analyzers.

The STA® - Quality HBPM/LMWH kit is a set of two plasmas intended for the quality control of low molecular weight heparin (LMWH) activity assay by measuring the anti-Xa activity performed on STA-R®, STA Compact, and STA Satellite® analyzers.

Device Description

The STA® - Liquid Anti-Xa is a chromogenic assay technique used for determination of the level of UFH and LMWH that have high affinity for antithrombin by measuring their anti-Xa activity. The method is a one-step reaction based on a similar principle: as soon as factor Xa is added to the plasma-substrate mixture, two reactions take place simultaneously, namely, hydrolysis of the substrate by factor Xa and inhibition of factor Xa by the heparin-antithrombin complex. After the necessary period of time for the competitive reaction to reach equilibrium, the quantity of paranitroaniline that is released is inversely proportional to the concentration of heparin present in the test medium.

The STA® - Multi Hep Calibrator reagents are lyophilized human plasmas at five different heparin concentrations. They are used to create the calibration curve on STA-R®, STA Compact®, and STA Satellite® analyzers performing the chromogenic method for heparin (UFH and LMWH) using STA® - Liquid Anti-Xa.

The STA® - Quality HNF/UFH reagents are lyophilized human plasmas at two different UFH concentrations. They are used for the quality control of UFH activity assay by measuring the anti-Xa activity using the chromogenic method STA® - Liquid Anti-Xa performed on STA-R®, STA Compact®, and STA Satellite® analyzers.

The STA® - Quality HBPM/LMWH reagents are lyophilized human plasmas at two different LMWH concentrations. They are used for the quality control of LMWH activity assay by measuring the anti-Xa activity using the chromogenic methods, STA® - Liquid Anti-Xa and STA® - Rotachrom® Heparin, performed on STA-R®, STA Compact, and STA Satellite® analyzers.

AI/ML Overview

The provided document describes the 510(k) summary for several in vitro diagnostic devices for measuring heparin activity. The document focuses on demonstrating substantial equivalence to predicate devices through performance characteristics, rather than establishing acceptance criteria and proving them with a specific study with a defined ground truth, as would be common for AI/ML device submissions.

Therefore, many of the requested elements (e.g., test set sample size, data provenance, number of experts for ground truth, adjudication method, MRMC study, training set details) are not applicable or not explicitly detailed in this type of submission.

However, I can extract information related to performance characteristics that serve as "acceptance criteria" for the device, and the studies performed to demonstrate these.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance characteristics of the STA® - Liquid Anti-Xa device (and its associated calibrator and controls) through precision and detection limit/working range studies. The "acceptance criteria" are implied by the ranges and values obtained, showing performance similar or superior to predicate devices or within acceptable analytical limits for IVD assays.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance	Comments
Precision (Hybrid Calibration - 5-point UFH/LMWH)	Coefficient of Variation (CV%) values within acceptable analytical limits for heparin assays. Specific numerical criteria are not explicitly stated, but common industry standards for IVD precision apply.	UFH Samples:- Sample 1 (mean 0.21 IU/mL): Repeatability CV 6.2%, Within-lab CV 9.9%- Sample 2 (mean 0.55 IU/mL): Repeatability CV 3.1%, Within-lab CV 6.6%- Sample 3 (mean 0.97 IU/mL): Repeatability CV 3.4%, Within-lab CV 5.5%LMWH Samples:- Sample 4 (mean 0.86 IU/mL): Repeatability CV 3.1%, Within-lab CV 4.8%- Sample 5 (mean 1.48 IU/mL): Repeatability CV 3.0%, Within-lab CV 5.1%- Sample 6 (mean 1.75 IU/mL): Repeatability CV 2.9%, Within-lab CV 5.0%	Performed according to CLSI guideline EP5-A2 over 22 days, 2 runs/day.
Precision (Dedicated Calibration - 3-point UFH)	CV% values within acceptable analytical limits.	UFH Samples:- Sample 1 (mean 0.22 IU/mL): Repeatability CV 5.6%, Within-lab CV 9.2%- Sample 2 (mean 0.55 IU/mL): Repeatability CV 3.0%, Within-lab CV 6.1%- Sample 3 (mean 0.97 IU/mL): Repeatability CV 3.5%, Within-lab CV 5.1%	Similar study design to hybrid calibration.
Precision (Dedicated Calibration - 3-point LMWH)	CV% values within acceptable analytical limits.	LMWH Samples:- Sample 4 (mean 0.86 IU/mL): Repeatability CV 3.2%, Within-lab CV 5.2%- Sample 5 (mean 1.48 IU/mL): Repeatability CV 3.1%, Within-lab CV 5.3%- Sample 6 (mean 1.75 IU/mL): Repeatability CV 2.8%, Within-lab CV 5.1%	Similar study design to hybrid calibration.
Detection Limit (UFH/LMWH 5-point calibration)	Detection threshold should be clinically relevant for heparin monitoring.	0.10 IU/mL (UFH and LMWH)	Assessed according to CLSI guideline EP17-A.
Linearity Range (UFH/LMWH 5-point calibration)	Linearity range should cover the clinically relevant range for heparin monitoring.	UFH: up to 1.10 IU/mL; LMWH: up to 2.00 anti-Xa IU/mL	Assessed according to CLSI guideline EP6-A.
Detection Limit (UFH 3-point calibration)	Detection threshold should be clinically relevant.	0.10 IU/mL	Assessed according to CLSI guideline EP17-A.
Linearity Range (UFH 3-point calibration)	Linearity range should cover the clinically relevant range.	up to 1.10 IU/mL	Assessed according to CLSI guideline EP6-A.
Detection Limit (LMWH 3-point calibration)	Detection threshold should be clinically relevant.	0.10 anti-Xa IU/mL	Assessed according to CLSI guideline EP17-A.
Linearity Range (LMWH 3-point calibration)	Linearity range should cover the clinically relevant range.	up to 2.00 anti-Xa IU/mL	Assessed according to CLSI guideline EP6-A.
Interfering Substances	No significant interference from common endogenous substances at clinically relevant concentrations.	Insensitive to: hemoglobin (up to 1.5 g/l), conjugated bilirubin (up to 288 mg/l), unconjugated bilirubin (up to 138 mg/l), triglycerides (up to 6.9 g/l).	Performed according to CLSI guideline EP7-A2.

2. Sample size used for the test set and the data provenance:

Test set sample size: For precision studies, 6 heparin samples (3 UFH, 3 LMWH) were used for each calibration type (hybrid and dedicated). For the detection limit and linearity studies, specific sample numbers are not provided but are implicit in the CLSI guidelines (EP17-A and EP6-A) which typically involve multiple replicates across different concentrations. For interfering substances, the number of samples is not explicitly stated, but the study tested specific concentrations of key interferents.
Data provenance: Not explicitly stated, but given this is an in vitro diagnostic device for global markets, the samples would likely be prepared laboratory controls and patient plasma samples (for linearity, detection limit, and interference studies), not geographically defined "countries of origin" in the same way as imaging data. The studies are prospective in the sense that they are designed experiments to validate performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable (N/A) in the context of this IVD device. The "ground truth" for these types of assays is established by the known concentrations of calibrators, controls, and spiked samples, or by reference methods, not by expert interpretation.

4. Adjudication method for the test set:

N/A. Adjudication is not relevant for analytical performance studies of quantitative IVD assays.

5. 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:

No. This is an in vitro diagnostic device, not an AI/ML-driven interpretive device typically associated with MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Yes, this is a standalone device. The performance characteristics (precision, detection limits, linearity, interference) are determined for the algorithm/device only. Human involvement is in operating the analyzer and interpreting the numerical results, but the analytical performance itself is inherent to the device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For precision, linearity, and detection limit, the ground truth is established by the known concentrations of the calibrators and control plasmas, or by accepted reference methods for heparin activity (e.g., anti-Xa activity).
For interfering substances, the ground truth is the addition of specific interfering agents at known concentrations to samples, and then assessing if the device's measurement of heparin is accurately maintained.

8. The sample size for the training set:

Not applicable (N/A) in the AI/ML sense. This is a traditional IVD device using established chromogenic assay principles, not an AI/ML system that requires a "training set" to learn. The method relies on biochemical reactions and quantitative measurement.

9. How the ground truth for the training set was established:

N/A for the same reason as point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the word "Stago" in a stylized font, with a symbol above it that resembles three curved shapes forming a circular pattern. Below the word "Stago", there is the text "510(k) Summary" in a smaller, bold font. The text indicates that the image is likely related to a summary document for a medical device or product requiring 510(k) clearance.

1822

OCT 2,6 2011

Submitter's Information

Diagnostica Stago, Inc. Five Century Drive Parsippany, New Jersey 07054

Phone: (973) 631-1200, x-4117 Facsimile: (973) 867-6859

Date Prepared: October 25, 2011

Application Correspondent and Contact Person:

Carlo d'Alessandro, Director, IVD Quality and Regulatory DONAWA LIFESCIENCE CONSULTING Piazza Albania, 10 - 00153 Rome, Italy Phone: +39 06 578 2665 Facsimile:+39 06 574 3786

Device Names :

Trade names(products sold separately)	Common names	Classification name	ProductCode
STA® - Liquid Anti-Xa	Heparin Assay	Heparin Assay21 CFR 864.7525	KFF
STA® - Multi Hep Calibrator	Heparin Calibrator	Calibrator, secondary21 CFR 862.1150	JIT
STA® - Quality HNF/UFH	Heparin Control	Plasma, coagulation control21 CFR 864.5425	GGN
STA® - Quality HBPM/LMWH	Heparin Control	Plasma, coagulation control21 CFR 864.5425	GGN

Predicate Devices

Predicate Device name	510(k) number
STA® - Rotachrom® Heparin	K010455
STA® - Calibrator HBPM/LMWH	K010350
STA® - Hepanorm® H{formerly cleared as Hepanorm®Calibration Plasma Set}	K854762
STA® - Heparin Control	K943520
STA® - Quality HBPM/LMWH	K010324

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a serif font, with a stylized graphic above it. The graphic appears to be composed of three curved shapes arranged in a circular pattern, creating a sense of movement or rotation.

Device Intended Use

STA® Liquid Anti-Xa: The STA® Liquid Anti-Xa kits are intended for use with STA-R®, V STA Compact® and STA Satellite® analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.
✔ STA® Multi Hep Calibrator: The STA® Multi Hep Calibrator is a set of calibrator plasmas intended for use with STA-R®, STA Compact®, and STA Satellite® analyzers, for the calibration of heparin (UFH and LMWH) activity assay by measuring the anti-Xa activity.
STA® Quality HNF/UFH: The STA® Quality HNF/UFH kit is a set of two plasmas > intended for the quality control of unfractionated heparin (UFH) activity assay by measuring the anti-Xa activity performed on STA-R®, STA Compact®, and STA Satellite® analyzers.
STA® Quality HBPM/LMWH: The STA® Quality HBPM/LMWH kit is a set of two > plasmas intended for the quality control of low molecular weight heparin (LMWH) activity assay by measuring the anti-Xa activity performed on STA-R®, STA Compact®, and STA Satellite®.

Device descriptions

✓ STA® - Liquid Anti-Xa:

The STA® - Liguid Anti-Xa is a chromogenic assay technique used for determination of the level of UFH and LMWH that have high affinity for antithrombin by measuring their anti-Xa activity.

The normal function of a molecule of factor Xa, when present in plasma, is to cleave its natural substrate, prothrombin, to generate thrombin, the enzyme responsible for the formation of the fibrin clot. In the presence of heparin, competition occurs between this mechanism and the inhibitory mechanism exerted by the heparin-antithrombin complex, this inhibition being largely responsible for the anticoagulant action of heparin.

The proposed method is a one-step reaction based on a similar principle: as soon as factor Xa is added to the plasma-substrate mixture, two reactions take place simultaneously, namely,

hydrolysis of the substrate by factor Xa
inhibition of factor Xa by the heparin-antithrombin complex*.

After the necessary period of time for the competitive reaction to reach equilibrium, the quantity of paranitroaniline that is released is inversely proportional to the concentration of heparin present in the test medium.

The heparin-antithrombin complex is made up from the heparin and the antithrombin (AT) peculiar to the patient.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a bold, sans-serif font, with a stylized graphic above it. The graphic appears to be an abstract shape, possibly representing a stylized leaf or a geometric design. The logo is simple and modern in appearance.

STA® - Multi Hep Calibrator >

Three kinds of calibration are possible, depending on the type of molecule to be determined:

a calibration with the Reagents 1, 2, 3, 4 and 5 for UFH and/or LMWH assays,
a calibration with the Reagents 1, 2 and 4 dedicated to UFH assays,
a calibration with the Reagents 1, 3 and 5 dedicated to LMWH assays.

✓ STA® - Quality HNF/UFH

> STA® - Quality HBPM/LMWH

Statement of technological characteristics of the device compared to predicate devices

STA® Liquid Anti-Xa is substantially equivalent to the predicate device, STA® V Rotachrom® Heparin (K010455) in indication/intended use, test principle, technology and performance thus yielding no new questions in safety and effectiveness.
STA® Multi Hep Calibrator is substantially equivalent to the predicate devices, STA® -> Calibrator HBPM/LMWH Kit (K010350) and STA® - Hepanorm® H (K854762) in indication/intended use, technology and performance, thus yielding no new questions in safety and effectiveness.

The primary difference between the subject product and predicate devices is that the new calibrator kit is intended for use with both Unfractionated and Low Molecular Weight Heparin testing.

STA® Quality HNF/UFH is substantially equivalent to the predicate device STA -> Heparin Control (K943520) in indication/intended use, technology and performance, thus yielding no new questions in safety and effectiveness.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a serif font, with a stylized graphic above it. The graphic appears to be an abstract shape, possibly representing a stylized leaf or a geometric design. The logo is in black and white.

STA® Quality HBPM/LMWH is substantially equivalent to the predicate device STA® -> HBPM/LMWH (K010324) in indication/intended use, technology and Quality performance, thus yielding no new questions in safety and effectiveness. The new STA® - Quality HBPM/LMWH is a modification to the current kit STA® - Quality HBPM/LMWH, the primary difference is that the new STA® - Quality HBPM/LMWH is intended for use with LMWH testing performed by STA® - Liquid Anti-Xa in addition to the current assay STA® - Rotachrom® Heparin (K010455).

Summary Performance Characteristics

Precision >
Precision studies were performed according to the CLSI guideline EP5-A2 using samples containing heparin (22 days, 2 runs per day). The following results have been obtained:

Hybrid calibration (5-point calibration)		Sample 1(UFH)	Sample 2(UFH)	Sample 3(UFH)	Sample 4(LMWH)	Sample 5(LMWH)	Sample 6(LMWH)
Mean	$X¯$	IU/mL	0.21	0.55	0.97	0.86	1.48	1.75
Repeatability	SD	IU/mL	0.013	0.017	0.033	0.027	0.045	0.050
	CV	%	6.2	3.1	3.4	3.1	3.0	2.9
Within-laboratoryprecision	SD	IU/mL	0.021	0.036	0.053	0.041	0.075	0.087
	CV	%	9.9	6.6	5.5	4.8	5.1	5.0

Dedicated calibration (3-point calibration)			Sample 1(UFH)	Sample 2(UFH)	Sample 3(UFH)	Sample 4(LMWH)	Sample 5(LMWH)	Sample 6(LMWH)
Mean	$\overline{X}$	IU/mL	0.22	0.55	0.97	0.86	1.48	1.75
Repeatability	SD	IU/mL	0.012	0.017	0.034	0.028	0.045	0.050
	CV	%	5.6	3.0	3.5	3.2	3.1	2.8
Within-laboratoryprecision	SD	IU/mL	0.020	0.033	0.050	0.045	0.078	0.089
	CV	%	9.2	6.1	5.1	5.2	5.3	5.1

V Detection Limit - Working Range
The limit of detection and linearity were assessed for each method according to the CLSI quidelines EP17-A and EP6-A respectively.

In the UFH/LMWH method with the STA® - Multi Hep Calibrator (5-point calibration) the detection threshold on the STA-R® is 0.10 IU/ml (UFH and LMWH) and the linearity range extends to 1.10 IU/ml for the UFH and to 2.00 anti-Xa IU/ml for the LMWH. In the UFH method with the STA® - Multi Hep Calibrator (UFH 3-point calibration), the detection threshold on the STA-R® is 0.10 IU/ml and the linearity range extends to 1.10 IU/ml.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the word "Stago" in a serif font, with each letter in lowercase except for the "S". Above the word is a stylized graphic that resembles a three-petal flower or a stylized letter "S". The logo is simple and clean, with a focus on the company name and a memorable visual element.

In the LMWH method with the STA® - Multi Hep Calibrator (LMWH,3-point calibration) the detection threshold on the STA-R® is 0.10 anti-Xa IU/ml and the linearity range extends to 2.00 anti-Xa IU/ml.

> Interfering substances

The STA® - Liquid Anti-Xa method (UFH and LMWH protocols) is insensitive to the following substances: hemoglobin (up to 1.5 g/l), conjugated bilirubin (up to 288 mg/l -342 µmol/), unconjugated bilirubin (up to 138 mg/l - 236 µmol/l) and triglycerides (up to 6.9 g/l - 8 mmol/l). The tests were performed according to the CLSI guideline EP7-A2.

{5}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/2 description: The image shows a seal for the Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged around the left side of the circle. On the right side of the circle is an abstract symbol that resembles an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Diagnostica Stago, S.A.S. c/o Mr. Carlo d'Alessandro Director, IVD Quality and Regulatory Donawa Lifescience Consulting Srl Piazza Albania, 10 Rome, Italy 00153

OCT 2 6 2011

Re: K111822

Trade/Device Name: STA®- Liquid Anti-Xa STA®-Multi Hep Calibrator STA®-Quality HNF/UFH STA®-HBPM/LMWH Regulation Number: 21 CFR § 864.7525 Regulation Name: Heparin Assay Regulatory Class: Class II Product Code: KFF; JIS; GGN Dated: September 22, 2011

Received: September 26, 2011

Dear Mr. d'Alessandro:

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

{6}------------------------------------------------

Page 2 – Mr. Carlo d'Alessandro

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 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 nredicate 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/ReportalProblem/default.h1m 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.

tor

Leuch. S.

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

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a serif font, with a stylized graphic above it. The graphic appears to be an abstract shape, possibly representing a stylized leaf or a curved, geometric form. The logo is simple and clean, with a focus on the company name and a distinctive visual element.

Indications for Use Statements 1.3

510(k) Number (if known): KII 1822

Device Name: STA® - Liquid Anti-Xa

Indications for Use:

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Leve R. L.

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K111822

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a serif font, with a stylized graphic above it. The graphic appears to be three curved shapes arranged in a circular pattern, resembling a stylized flower or abstract design. The logo is black and white.

510(k) Number (if known): K111822

Device Name: STA® - Multi Hep Calibrator

Indications for Use:

The STA® - Multi Hep Calibrator is a set of calibrator plasmas intended for use with STA-R®, STA Compact® and STA Satellite® analyzers, for the calibration of heparin (UFH and LMWH) activity assay by measuring the anti-Xa activity.

Prescription Use × (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 OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K111822

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a serif font, with a stylized graphic above it. The graphic appears to be three curved shapes arranged in a circular pattern, resembling a stylized eye or a partially opened flower. The logo is black and white.

510(k) Number (if known): K111822

Device Name: STA® - Quality HNF/UFH

Indications for Use:

Prescription Use × (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 OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Semt. L. Si.

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K111822

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the logo for Stago. The logo consists of the word "Stago" in a sans-serif font, with a stylized graphic above it. The graphic appears to be composed of three curved shapes arranged in a circular fashion, creating a sense of movement or rotation.

510(k) Number (if known): K111822

Device Name: STA® - Quality HBPM/LMWH

Indications for Use:

Prescription Use × (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 OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Leach R.S.

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K111822

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).