(23 days)
Sigma Diagnostics ACCUCLOT™ Control I is a human plasma control that is suitable for use as a normal control with patient citrated plasma in the one-stage prothrombin time (PT), in the activated partial thromboplastin time (APTT), in thrombin time, in the chromogenic Antithrombin III (AT-III) assay and in fibrinogen determinations using a clotting method. Plasma controls are routinely used in the coagulation laboratory as a means of quality control for coagulation testing.
Sigma Diagnostics ACCUCLOT™ Control I is a lyophilized human plasma based product. After reconstitution with water, ACCUCLOT™ Control I is stable for 48 hours when stored at 2-8°C.
The provided text describes a 510(k) summary for the Sigma Diagnostics ACCUCLOT™ Control I. This document primarily focuses on establishing "substantial equivalence" to a predicate device, rather than presenting a performance study with detailed acceptance criteria and results. Therefore, many of the requested details about a study proving the device meets acceptance criteria are not found in this document.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of specific numerical thresholds (e.g., accuracy, precision, sensitivity, specificity). Instead, the performance is demonstrated through its "substantial equivalence" to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Sigma Diagnostics Coagulation Control, Level I (Cat. No. 7916) | The safety and effectiveness of the Sigma Diagnostics ACCUCLOT™ Control I has been demonstrated by its substantial equivalence to the Sigma Diagnostics Coagulation Control, Level I (Cat. No. 7916). |
| Stability | After reconstitution with water, ACCUCLOT™ Control I is stable for 48 hours when stored at 2-8°C. |
| Intended Use | Suitable for use as a normal control with patient citrated plasma in one-stage prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time, chromogenic Antithrombin III (AT-III) assay, and fibrinogen determinations using a clotting method. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given text. A 510(k) summary for a control product often focuses on manufacturing consistency and equivalence to an existing product rather than a large-scale clinical test set involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided. The assessment of "substantial equivalence" is typically conducted by the FDA reviewers based on the manufacturer's submission, and does not involve external experts establishing a ground truth for a test set in the same way a diagnostic algorithm might be evaluated.
4. Adjudication Method for the Test Set
This information is not provided. As there's no mention of a test set with individual cases requiring ground truth, no adjudication method would be detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not mentioned in this 510(k) summary. This type of study is typically performed for diagnostic imaging algorithms to assess the impact of AI on human reader performance. ACCUCLOT™ Control I is a laboratory control, not a diagnostic algorithm that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study in the context of an algorithm's performance was not done. ACCUCLOT™ Control I is a biochemical control product, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" used is the performance and characteristics of the predicate device, Sigma Diagnostics Coagulation Control, Level I (Cat. No. 7916). The equivalence to this established product serves as the benchmark. For the control itself, its inherent properties (e.g., coagulation factor levels, stability) compared to expected normal ranges would also implicitly serve as a "ground truth" in its development and manufacturing, but this is not explicitly detailed as a ground truth type for a study here.
8. Sample Size for the Training Set
This information is not applicable/provided. ACCUCLOT™ Control I is a physical control product, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided. No training set is involved for this type of device.
In summary: The provided 510(k) document is for a laboratory control product and focuses on establishing "substantial equivalence" to a predicate device. It does not contain the detailed performance study information with specific acceptance criteria, sample sizes, expert ground truth, or AI-related study types that are often associated with diagnostic algorithms.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS APR 2 9 1998 ACCUCLOTTM Control I, Cat. No. A4089
Sigma Diagnostics ACCUCLOT™ Control I is a human plasma control that is suitable for use as a normal control with patient citrated plasma in the one-stage prothrombin time (PT), in the activated partial thromboplastin time (APTT), in thrombin time, in the chromogenic Antithrombin III (AT-III) assay and in fibrinogen determinations using a clotting method.
The safety and effectiveness of the Sigma Diagnostics ACCUCLOT™ Control I has been demonstrated by its substantial equivalence to the Sigma Diagnostics Coagulation Control, Level I (Cat. No. 7916). >>
Sigma Diagnostics ACCUCLOT™ Control I is a lyophilized human plasma based product. After reconstitution with water, ACCUCLOT™ Control I is stable for 48 hours when stored at 2-8°C.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 9 1998
William Gilbert, Ph.D. . Manager, Scientific Affairs Sigma Diagnostics Inc. 545 South Ewinq Avenue St. Louis, Missouri 63103
Re : K981248 ACCUCLOT™ Control I Regulatory Class: II Product Code: GIZ, GGN Dated: April 2, 1998 Received: April 6, 1998
Dear Dr. Gilbert:
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 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 general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉੱ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. 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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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/dsmamain.html".
Sincerely yours,
Steven Sitman
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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510(k) Number (if known):
Device Name: Sigma Diagnostics ACCUCLOT™ CONTROL I
Indications For Use:
Arania
Sigma Diagnostics ACCUCLOT™ CONTROL I is a human plasma control that is suitable for use as a normal control with patient citrated plasma in the one-stage prothrombin time (PT), in the activated partial thromboplastin time (APTT), in thrombin time, in the chromogenic Antithrombin III (AT-III) assay and in fibrinogen determinations using a clotting method. Plasma controls are routinely used in the coagulation laboratory as a means of quality control for coagulation testing.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Divis Divis S10(k) J
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use _
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§ 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.