The gbACT+ Kit is an in-vitro diagnostic product designed for use with the Sonoclot Coagulation & Platelet Function Analyzer System. The gbACT+ test is an activated whole blood clotting time test. It may also be used with citrated whole blood or plasma. The gbACT+ Kit is intended for general purpose global hemostasis monitoring including: clot detection, fibrin formation, platelet function, and hyperfibrinolysis. The monitoring information is typically used for anticoagulant management at low to moderate heparin levels (1 to 2 units per ml), hypercoagulable and/or hypocoagulable screening, platelet function assessment, and hyperfibrinolysis screening.

Device Description

The gbACT+ Kit is an in-vitro diagnostic product designed for use with the Sonoclot Coagulation & Platelet Function Analyzer System. Each kit contains glass bead cuvettes, probes and instructions for use. Current package sizes of 100 (#800-0412) and 24 (#800-0411) tests are available. The lidded pink cuvettes contain a controlled amount of the glass bead activator and a magnetic stir bar. A mason box is used for the kit package.

AI/ML Overview

The provided text describes the gbACT+ Kit and claims substantial equivalence to the predicate device, the SonACT Kit. However, it does not include detailed "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the way typically expected for a modern medical device submission with specific performance metrics and statistical analysis.

Instead, the submission primarily focuses on technological characteristic comparison and typical results for both the new device (gbACT+) and the predicate device (SonACT). The implicit acceptance criteria seems to be that the gbACT+ Kit produces "normal ranges" of results that are comparable or acceptable within the context of activated whole blood clotting time tests, and that its performance characteristics are similar to the predicate device.

Here's an attempt to extract and present the information based on the provided text, acknowledging its limitations regarding explicit acceptance criteria and detailed study methodology:

1. Table of acceptance criteria and the reported device performance

Since explicit "acceptance criteria" (e.g., "sensitivity must be >X%, specificity >Y%") are not provided, I'll infer them from the "Normal Range" values presented for both devices and their intended use. The performance reported for the gbACT+ is its "Normal Range" in comparison to the predicate.

Performance Metric	Acceptance Criteria (Inferred from Predicate's Normal Range and Intended Use)	Reported Device Performance (gbACT+ Normal Range)
ACT/Onset (Native Whole Blood - Normal Population, No Heparin)	Produce an ACT/Onset within a clinically acceptable range for activated whole blood clotting time, comparable to or improving upon the predicate. Predicate range: 85-145 seconds.	125 - 220 seconds
Clot RATE (Native Whole Blood - Normal Population, No Heparin)	Produce a Clot RATE within a clinically acceptable range. Predicate range: 15-45 Clot Signal Units / minute.	10-45 Clot Signal Units / minute
Time to Peak (Native Whole Blood - Normal Population, No Heparin)	Produce a Time to Peak within a clinically acceptable range. Predicate range: <30 minutes.	<20 minutes
Intended Use	General purpose global hemostasis monitoring, hypercoagulable and hyperfibrinolysis screening, platelet function assessment, anticoagulation management (low to moderate heparin levels).	Same as acceptance criteria (explicitly stated).

Interpretation of "Acceptance": The "acceptance" is implicitly demonstrated by presenting typical results within normal ranges for the new device and comparing them side-by-side with the predicate's typical results, indicating that the new device functions similarly and produces relevant clinical information. The FDA's 510(k) clearance implies that these comparisons were deemed sufficient for substantial equivalence.

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

Sample Size: Not explicitly stated. The document refers to "Normal Population, No Heparin" for "Native Whole Blood" and provides "Typical Results and Examples" (Normal A, Normal B). This suggests a small, unspecified number of subjects were tested to generate these "typical" values, rather than a large formal clinical trial with a defined sample size.
Data Provenance: Not explicitly stated. Likely collected in the USA, as the company address is in Wheat Ridge, CO, USA. The data appears to be prospective in the sense that testing was performed to establish normal ranges for the device, but the methodology of this testing is not detailed.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.
Ground Truth Establishment: The "Normal Range" values are presented as established values, but the method by which they were established (e.g., consensus, previous studies, clinical guidelines) or who established them is not detailed.

4. Adjudication method for the test set

Adjudication method: Not described or mentioned.

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

MRMC Study: Not applicable. This device is an in-vitro diagnostic kit for coagulation testing, not an imaging device or AI-assisted diagnostic tool that would involve multiple human readers interpreting results.

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

The gbACT+ Kit is an in-vitro diagnostic product used with the Sonoclot Coagulation & Platelet Function Analyzer System. The analyzer itself performs the measurement and provides quantitative and qualitative results. The "performance" described here is of the kit (reagent cuvettes), not an AI algorithm. So, while it's a "standalone" test in the sense that the analyzer produces objective measurements, it is not an "algorithm-only" performance in the context of AI. The performance is of the device system (kit + analyzer) without human interpretive input for the primary measurements.

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

The ground truth for the "normal ranges" is implicitly defined by established clinical norms or reference values for activated whole blood clotting time parameters. It does not explicitly mention pathology, expert consensus, or outcomes data as the direct ground truth for these specific ranges, but rather refers to a "Normal Population, No Heparin."

8. The sample size for the training set

Not applicable. The gbACT+ Kit is a reagent kit, not a machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary of Limitations in the Provided Text:

The provided 510(k) summary is from 1998/1999 and reflects the regulatory expectations of that era. For a modern AI/ML device, the level of detail regarding acceptance criteria, study design, sample sizes, ground truth establishment, and expert involvement would be significantly more extensive and rigorous. This document focuses on demonstrating substantial equivalence to a predicate device primarily through comparative tables of technological characteristics and typical performance ranges, rather than detailed statistical evidence meeting pre-defined acceptance criteria from a formal clinical study.

Summary

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MAY 28 1000 Sienco, Inc. 4892 Van Gordon St. - Unit 203 Wheat Ridge, CO USA 80033 303/420-2204(Fax) 303/420-1148 800/432-1624

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: _K 984 141

(1) Contact Person: Barbara DeBiase, Director, Sienco Inc. Summary Preparation Date: 1 November 1998
(2) Device Trade Name: gbACT+ Kit Common Name: Activated Clotting Time (ACT) Test Classification Name: Activate Whole Blood Clotting Time Test Classification: Class II, 21 CFR 864.7140
(3) Identification of predicate device to which substantial equivalence is being claimed: SonACT Kit, 510(k) # K952560
(4) and (5) Device Description and Intended Use: The gbACT+ Kit is an in-vitro diagnostic product designed for use with the Sonoclot Coagulation & Platelet Function Analyzer System. Each kit contains glass bead cuvettes, probes and instructions for use. Current package sizes of 100 (#800-0412) and 24 (#800-0411) tests are available. The lidded pink cuvettes contain a controlled amount of the glass bead activator and a magnetic stir bar. A mason box is used for the kit package.

The gbACT+ test is an activated whole blood clotting time test. It may also be used with citrated whole blood or plasma. The gbACT+ Kit is intended for general purpose global hemostasis monitoring including: clot detection, fibrin formation, platelet function, and hyperfibrinolysis. The monitoring information is typically used for anticoagulant management at low to moderate heparin levels (1 to 2 units per ml), hypercoagulable and/or hypocoagulable screening, platelet function assessment, and hyperfibrinolysis screening.

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(6) Technological Characteristic Comparison of the gbACT+ Kit to the standard SonACT Kit:

ITEM	gbACT+	STANDARD SONACT
Classification Name	Activated Whole Blood ClottingTime Test	Activated Whole Blood ClottingTime Test
IVD Reagent forUse With	Sonoclot Coagulation & PlateletFunction Analyzer	Sonoclot Coagulation & PlateletFunction Analyzer
Intended Use	General purpose global hemostasismonitoring, hypercoagulable andhyperfibrinolysis screening,platelet function assessment,anticoagulation management (lowto moderate heparin levels)	General purpose global hemostasismonitoring, hypercoagulable andhyperfibrinolysis screening,platelet function assessment,anticoagulation management (lowto high heparin levels)
Results Provided	Quantitative results for ActivatedClotting Time (Onset /ACT Time).Qualitative and quantitative fibrinformation information (Clot RATE,Sonoclot Signature). Qualitativeand quantitative platelet functioninformation from SonoclotSignature. Qualitative andquantitative hyperfibrinolysisinformation from SonoclotSignature.	Quantitative results for ActivatedClotting Time (Onset/ACT Time).Qualitative and quantitative fibrinformation information (Clot RATESonoclot Signature). Qualitativeand quantitative platelet functioninformation from SonoclotSignature. Qualitative andquantitative hyperfibrinolysisinformation from SonoclotSignature.
Test Design	Pink plastic lidded cuvettecontaining contact activator (glassbeads ) and magnetic stir bar	Colorless plastic lidded cuvettecontaining contact activator (celite)and magnetic stir bar
Kit Contents	Cuvettes, probes and instructionsfor use	Cuvettes, probes and instructionsfor use
Quality Control	Reference Plasma Quality ControlKit, Sienco part #900-1318	Reference Plasma Quality ControlKit, Sienco part #900-1318

510(k) Summary - Page 2 of 3

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(7) Performance Comparison of the gbACT+ Kit to the standard SonACT Kitt Expected
Performance Comparison of the goACT The to the standard SonACT in the lables below.
values for the gbACT+ Kit and the standard SonACT to estandard values for the gDACT+ Tric and the standard Somro-Print as pro-SonACT test are also included.

gbACT+ Typical Results and Examples

gbACT+ Test (#800-0411, 800-0412)Native Whole Blood - Normal Population, No Heparin
Result	Normal Range
ACT/Onset	125 - 220 seconds
Clot RATE	10-45 Clot Signal Units / minute
Time to Peak	<20 minutes

Normal A: Native Whole Blood: gbACT+

Image /page/2/Figure/4 description: The image shows three lines of text related to medical measurements. The first line reads "Onset/ACT: 167", indicating a value of 167 for Onset/ACT. The second line reads "ClotRATE: 15", indicating a ClotRATE value of 15. The third line reads "Time to Peak: 8", indicating a Time to Peak value of 8.

Image /page/2/Figure/5 description: The image shows a graph of a clot signal over time. The y-axis represents the clot signal, and the x-axis represents time. The graph shows an initial increase in the clot signal, followed by a peak, and then a gradual decrease. The onset is labeled as 169, and the rate is 15.

Normal B: Native Whole Blood: gbACT+

Onset/ACT: 149 ClotRATE: 9 Time to Peak: 12

Image /page/2/Figure/20 description: The image shows a graph of a clot signal. The x-axis is labeled "SIEN.D. INC." and ranges from 0 to 20. The y-axis is labeled "Clot Signal" and ranges from 0 to 120. The graph shows two peaks, one at approximately x=5 and y=40, and another at approximately x=12 and y=80. The text "Onset=149" and "帆-1.3" are also visible on the graph.

SonACT Typical Results and Examples for Comparison

Standard SonACT Test (#800-0432, #800-0431)Native Whole Blood - Normal Population, No Heparin
Result	Normal Range
ACT/Onset	85-145 seconds
Clot RATE	15-45 Clot Signal Units / minute
Time to Peak	<30 minutes

Normal A: Native Whole Blood: SonACT

Image /page/2/Figure/12 description: The image shows a graph of clot signal over time. The graph shows an initial increase in clot signal, followed by a peak and then a gradual decrease. The image also includes some text, which indicates that the onset/ACT is 89, the clot rate is 22, and the time to peak is 17. The y axis is labeled clot signal and the x axis is not labeled.

Normal B: Native Whole Blood: SonACT

Image /page/2/Figure/14 description: The image shows a graph of a clot signal over time. The graph shows the clot signal increasing to a peak, then decreasing. The image also includes the following values: Onset/ACT: 91, ClotRATE: 10, and Time to Peak: 20.

Barbara DeBiase, Director

rbara DeBiase, Director

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Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is a stylized image of an eagle with three lines representing its wings. The eagle is facing to the right.

MAY 2 8 1939

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Barbara Debiase SIENCO, INC. 4892 Van Gordon Street Unit 203 80033 Wheatridge, CO

Re: K984141 Trade Name: gbACT + Kit Requlatory Class: II Product Code: JBP Dated: May 11, 1999 Received: May 12, 1999
Dear Ms. Debiase:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the qeneral 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours.

Steven Sutman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_ 1_of_1

510(k) Number (if known): $944 / 41

Device Name:

Indications For Use:

The gbACT+ Kit is an in-vitro diagnostic product designed for use with the Sonoclot Coagulation & Platelet Function Analyzer System. The gbACT+ test is an activated whole blood clotting time test. It may also be used with citrated whole blood or plasma. The gbACT+ Kit is intended for general purpose global hemostasis monitoring including: clot detection, fibrin formation, platelet function, and hyperfibrinolysis. The monitoring information is typically used for anticoagulant management at low to moderate heparin levels (0 to 2 units per ml), hypercoagulable and/or hypocoagulable screening, platelet function assessment, and hyperfibrinolysis screening.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K984141

Prescription Use	✓
(Per 21 CFR 801.109)

Over-The-Counter Use	_________________
(Optional Format 1-2-96)

Regulation Number and Section

§ 864.7140 Activated whole blood clotting time tests.

(a)
Identification. An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.(b)
Classification. Class II (performance standards).