The Actim PROM test is a visually interpreted, qualitative immunochromatographic rapid test for the detection of amniotic fluid in cervicovaginal secretions during pregnancy. Actim PROM test detects IGFBP-1, which is a major protein in amniotic fluid and a marker of the presence of amniotic fluid in a cervicovaginal sample. The test is intended for professional use to help diagnose the rupture of fetal membranes (ROM) in pregnant women at >34 weeks gestation when patients report signs, symptoms or complaints suggestive of ROM or if such signs are otherwise observed.

The Actim PROM Controls are intended for use as external controls with the Actim PROM test. The controls may also be used to demonstrate negative results and weak and strong positive results.

Device Description

The Actim PROM is a rapid test for detection of premature rupture of fetal membranes. The test principle is lateral flow immunochromatography. Actim PROM is available in packages of 3, 10 and 20 tests. Each individual test pack contains a sterile polyester swab, specimen extraction solution and a dipstick. The dipstick is packed in a foil pouch with desiccant.

The Actim PROM Controls contain one vial each of negative, low positive and high positive controls, and reconstitution solution.

AI/ML Overview

Acceptance Criteria and Study for Medix Biochemica Actim PROM

The provided text describes the Actim PROM device but does not explicitly state specific acceptance criteria in a quantifiable table format or a detailed study proving performance against such criteria. Instead, it broadly mentions "Performance Testing" and that the device "performed according to its specifications."

However, based on the context of the 510(k) submission, the implicit acceptance criteria are that the device demonstrates substantial equivalence to the predicate device (AmniSure ROM Test) in terms of safety and effectiveness for its intended use. This typically involves demonstrating comparable performance characteristics.

Here's an analysis based on the provided text, highlighting what is and is not available:

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, explicit acceptance criteria values (e.g., specific sensitivity, specificity, accuracy thresholds) are not provided in the document for the Actim PROM. The document primarily focuses on stating that various performance studies were conducted and that the device met its specifications.

Acceptance Criteria Category	Specific Acceptance Criteria (Not Explicitly Stated)	Device Performance (From Text)
Method Comparison	Implicit: Comparable performance to predicate device.	Studies demonstrated satisfactory method comparison.
Repeatability	Implicit: Consistent results under same conditions.	Studies demonstrated satisfactory repeatability.
Reproducibility	Implicit: Consistent results under varying conditions.	Studies demonstrated satisfactory reproducibility.
Analytical Sensitivity	Implicit: Detects relevant analyte at appropriate concentrations.	Studies demonstrated satisfactory analytical sensitivity.
Analytical Specificity	Implicit: Does not react with interfering substances.	Studies demonstrated satisfactory analytical specificity.
Interfering Substances	Implicit: Unaffected by common interfering substances.	Studies demonstrated satisfactory performance regarding interfering substances.
Intended Use	Implicit: Accurately aids in ROM diagnosis.	"The results of all studies demonstrated that the Actim PROM and Actim PROM Controls performed according to their specifications."

Note: The "Device Performance" entries above are direct interpretations of the statement "The results of all studies demonstrated that the Actim PROM and Actim PROM Controls performed according to their specifications." No specific quantitative results (e.g., sensitivity, specificity percentages, LOD, LOQ) are provided in this regulatory summary.

2. Sample Size for the Test Set and Data Provenance

The document states: "A series of nonclinical studies was conducted to assess the performance of the Actim PROM and Actim PROM Controls."

Sample Size for Test Set: Not specified. The text does not provide any information about the number of samples used in the performance testing.
Data Provenance: The document does not specify the country of origin of the data. It mentions Medix Biochemica in Finland (applicant) and the contact person in the US, but this does not indicate where the studies were conducted or the origin of patient samples.
Retrospective or Prospective: Not specified. The nature of the studies (retrospective or prospective) is not mentioned.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not specified. The document does not mention the use of experts to establish ground truth for the test set. Given the "nonclinical studies" and focus on analytical performance, it's possible that clinical ground truth (e.g., based on physician diagnosis or pathology) was used in a clinical study, but no details are provided here.
Qualifications of Experts: Not specified. No information is given about the qualifications of any potential experts.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. There is no mention of an adjudication method in the provided text.

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

MRMC Study: No, it was not done or at least not reported. The document describes "nonclinical studies" for analytical performance. It does not mention a clinical study involving human readers, a comparison of human readers with and without AI assistance, or any effect size.

6. Standalone Performance Study (Algorithm Only)

Standalone Performance: Yes, implicitly. The "Performance Testing" section describes studies on the device's analytical performance (method comparison, repeatability, reproducibility, analytical sensitivity, analytical specificity, interfering substances). Since the device is a "visually interpreted, qualitative immunochromatographic rapid test," these tests assess the device's ability to produce a result independent of further human interpretation beyond simple visual inspection of the test line. There is no complex algorithm involved beyond the chemical reaction and visual readout.

7. Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated, but likely based on analytical standards and reference methods. Given the description of "nonclinical studies" assessing aspects like analytical sensitivity and specificity, the ground truth would typically be established using known concentrations of the analyte (IGFBP-1) or by using samples confirmed positive/negative by a gold-standard reference method (if applicable for comparison). For clinical aspects, the ground truth for rupture of membranes might be based on clinical diagnosis, but this is not detailed for the "test set" in this summary.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable/Not specified. This device is a rapid diagnostic test, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The development of such a device involves iterative testing and refinement, but not a distinct "training set" for an algorithm.

9. How Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable. As explained above, the concept of a "training set" and associated ground truth establishment is not relevant to this type of immunochromatographic rapid test.

Summary

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510(k) Summary for the Medix Biochemica Actim PROM

1. Applicant/Sponsor

Medix Biochemica Asematie 13 02700 Kauniainen Finland

Contact Person:	Heli Paloheimo
Telephone:	358 9 547 680

Date Prepared: January 5, 2007

2. Device Name

Proprietary Name:	Actim PROM and Actim PROM Controls
Common/Usual Name:	Rupture Of Fetal Membranes (ROM) Rapid DiagnosticTest
Classification Name:	Urinary pH (Nonquantitative) Test System andQuality Control Material (Assayed and Unassayed)

3. Predicate Device

AmniSure ROM (Rupture Of [fetal] Membranes) Test N-Dia, Inc. K030849

4. Device Description

The Actim PROM is a rapid test for detection of premature rupture of fetal The test principle is lateral flow immunochromatography. Actim membranes. PROM is available in packages of 3, 10 and 20 tests. Each individual test pack contains a sterile polyester swab, specimen extraction solution and a dipstick. The dipstick is packed in a foil pouch with desiccant.

The Actim PROM Controls contain one vial each of negative, low positive and high positive controls, and reconstitution solution.

Page 1 of 2

JAN 2 5 2007

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న. Intended Use

The Actim PROM Controls are intended for use as external controls with the Actim PROM test. The controls may also be used to demonstrate negative results and weak and strong positive results.

6. Technological Characteristics and Substantial Equivalence

The Actim PROM and the predicate device cited above are both qualitative, lateral flow immunochromatographic assays intended to aid in detecting rupture of fetal membranes in pregnant women. Detection of results is by visual inspection for both tests. The analytes detected by both the Actim PROM and AmniSure tests are thought to be very similar. The specimen collection and extraction, test procedure, and reading and interpretation of results is similar between the two devices. Both devices are intended for use in point-of-care and clinical laboratory settings.

The differences between the Actim PROM and the predicate device do not impact the safety or effectiveness of the proposed Actim PROM products for their intended uses.

7. Performance Testing

A series of nonclinical studies was conducted to assess the performance of the Actim PROM and Actim PROM Controls. These studies evaluated method comparison, repeatability, reproducibility, analytical sensitivity, analytical specificity and interfering substances. The results of all studies demonstrated that the Actim PROM and Actim PROM Controls performed according to their specifications.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Cynthia Sinclair Medix Biochemica 49 Plain Street North Attelboro, MA 02760

Re: K061886

Trade/Device Name: Actim PROM Regulation Number: 21 CFR§862.1550 Regulation Name: Urinary pH (nonquantitative) test system. Regulatory Class: Class I Product Code: OAM, JJX Dated: November 29, 2006 Received: November 30, 2006

JAN 2 5 2007

Dear Ms. Sinclair:

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 misbrandijils 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Party 200).

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Page 2 -

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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Coopers, M.S., D.V.M.

Yéan M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K061886

Device Name: Actim PROM

Indications for Use:

The Actim PROM Controls are intended for use as external controls with the Actim PROM test. The controls may also be used to demonstrate negative results and weak and strong positive results.

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Carol C. Benson
sign-Off

്ലം of In Vitro Diagnostic Devices · 'eation and Safety

12061886

Medix Biochemica Additional Information - K061886 January 5, 2007

Regulation Number and Section

§ 862.1550 Urinary pH (nonquantitative) test system.

(a)
Identification. A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.