(23 days)
Sigma Diagnostics ACCUCLOT™ CONTROL II is a human plasma control that is suitable for use as an abnormal control with patient citrated plasma in the one-stage prothrombin time (PT), in the activated partial thromboplastin time (APTT), 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 II is a lyophilized human plasma based product. After reconstitution with water, ACCUCLOT™ Control II is stable for 48 hours when stored at 2-8°C.
The provided text describes a 510(k) submission for a medical device (ACCUCLOT™ Control II) that is seeking substantial equivalence to a predicate device (Sigma Diagnostics Coagulation Control, Level II). The document focuses on regulatory approval rather than a detailed device performance study against specific, quantified acceptance criteria.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this type of regulatory submission. The primary "study" proving its meeting of criteria is the demonstration of substantial equivalence to a previously approved device.
Here's an attempt to answer based on the provided text, with many fields indicating "Not specified" or "Not applicable" due to the nature of the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Criterion: Substantial Equivalence to Predicate Device | Device is substantially equivalent to Sigma Diagnostics Coagulation Control, Level II (Cat. No. 8916). |
| Functionality as an abnormal control in: | Demonstrated through substantial equivalence. Specific performance metrics (e.g., specific PT, APTT, AT-III, or fibrinogen values/ranges) are not provided in this summary but would have been part of the underlying data submitted for equivalence. |
| - One-stage prothrombin time (PT) | |
| - Activated partial thromboplastin time (APTT) | |
| - Chromogenic Antithrombin III (AT-III) assay | |
| - Fibrinogen determinations (clotting method) | |
| Stability after reconstitution (48 hours at 2-8°C) | Stated as a characteristic of the device. Direct performance data demonstrating this stability within performance specifications are not provided in this summary but would have been part of the submission. |
2. Sample sized used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The submission relies on demonstrating equivalence, which likely involved comparative testing, but the number of samples used for this comparison is not detailed here.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/Not specified. For substantial equivalence of a control material, ground truth isn't typically established by expert consensus on individual cases in the same way it would be for a diagnostic algorithm. Performance is assessed against a predicate device.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/Not specified.
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: No, this is not applicable. This device is a plasma control material, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a diagnostic reagent/control, not an algorithm. Its performance is intrinsic to the material itself when used in laboratory assays.
7. The type of ground truth used
- Type of Ground Truth: For a control material, "ground truth" would implicitly refer to its established and expected performance characteristics (e.g., target ranges for clotting times or AT-III activity) when run on validated diagnostic systems. The study likely involved demonstrating that the ACCUCLOT™ Control II performed within acceptable ranges relative to the Sigma Diagnostics Coagulation Control, Level II. The specific values or ranges are not provided here.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable. This is a manufactured control product, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not applicable.
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APR 2 9 1998 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ACCUCLOTTM Control II, Cat. No. A5089
Sigma Diagnostics ACCUCLOT™ Control II is a human plasma control that is suitable for use as a abnormal control with patient citrated plasma in the one-stage prothrombin time (PT), in the activated partial thromboplastin time (APTT), 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 II has been demonstrated by its substantial equivalence to the Sigma Diagnostics Coagulation Control, Level II (Cat. No. 8916). >>
Sigma Diagnostics ACCUCLOT™ Control II is a lyophilized human plasma based product. After reconstitution with water, ACCUCLOT™ Control II is stable for 48 hours when stored at 2-8°C.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the HHS emblem, which is a stylized representation of a human figure. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular pattern around the emblem.
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 Ewing Avenue St. Louis, Missouri 63103
Re : K981254 ACCUCLOT™ Control II Regulatory Class: II Product Code: GGC, 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. 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 requlation (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 In addition, FDA may publish further announcements action. 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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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 Litman
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): _ 1298 / 7
Device Name: Sigma Diagnostics ACCUCLOT™ CONTROL II
Indications For Use:
Sigma Diagnostics ACCUCLOT™ CONTROL II is a human plasma control that is suitable for use as an abnormal control with patient citrated plasma in the one-stage prothrombin time (PT), in the activated partial thromboplastin time (APTT), 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)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K981254
Prescription Use__
(Per 21 CFR 801.109)
OR
Over-The-Counter Use__
§ 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.